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Crédits
Devices
Device Recall Umbilicup
Modèle / numéro de série
Lot Numbers: 23383104, 24246953, 24328238, 24557401, 24797341, 24947178, 25112885, 25139279, 25373479, 25601267, 25831994, 26197358, 26634706, 26874806, 27121161, 27228507, 27467209
Classification du dispositif
Hematology and Pathology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.
Description du dispositif
DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849 || Product Usage: Collection of cord blood
Manufacturer
DeRoyal Industries Inc
1 Event
Rappel de Device Recall Umbilicup
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Fabricant
DeRoyal Industries Inc
Adresse du fabricant
DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
Société-mère du fabricant (2017)
Deroyal Industries Inc.
Source
USFDA
2 dispositifs médicaux avec un nom similaire
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Device Recall Umbilicup
Modèle / numéro de série
REF 89-5260.04, Lot Numbers: 17636582, 18080838, 18146577, 18178608, 18298693, 18952510, 19419055, 19480569, 19518336, 19592131, 19901141, 20128925, 20176492, 20678329, 20724372, 20822626, 21815858, 21923306, 22732536, 24157900, 24291754, 24630752, 24747336, 24823319, 25460353, 25721453, 25784489, 26018591, 26037952, 26149090, 26280549, 27163133, 27206527; REF 89-3928.10, Lot Numbers: 17826968, 17857924, 18177242, 18407790, 19021830, 19140417, 19676836, 20009408, 20127383, 20495653, 20676711, 20887981, 21023367, 21184339, 21531020, 21717131, 21839219, 22016935, 22057411, 22204397, 22379218, 22585169, 22731293, 23094151, 23420711, 23874561, 24230804, 24429928, 24519157, 24774801, 26098270, 26316468, 26663347, 26728235, 26956844, 27180961, 27343071, 27826304, 27911550, 27931729; REF 89-2960.20, Lot Numbers: 17903599, 17935806, 18183757, 19140610, 19325542, 19480673, 19881274, 20208693, 20679330, 20822829, 21056863, 21067909, 21318966, 21422472, 21649319, 21816375, 22123933, 22587164, 22782189, 23422927, 23696522, 23949622, 24007645, 24073423, 24232105, 24432131, 24468732, 24576258, 24823474, 26019527, 26281120, 26368444, 26785141, 26923452, 27227192, 27473916, 27931868
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.
Description du dispositif
Sterile surgical kits containing the Umbilicup device: || DeRoyal (R) VAGINAL DELIVERY PACK, REF 89-5260.04, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 || DeRoyal (R) VAGINAL DELIVERY TRAY, REF 89-3928.10, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 || DeRoyal (R) C-SECTION TRAY, REF 89-2960.20, Rx Only, STERILE EO, Manufacturer: DeRoyal, Powell, TN 37849 || Product Usage: Collection of cord blood
Manufacturer
DeRoyal Industries Inc
Device Recall Umbilicup
Modèle / numéro de série
Lot Numbers: 17486924, 17920399, 18040342, 18316290, 18551118, 19341884, 19396771, 19464008, 19504031, 19546960, 19743023, 20687057, 21157488, 21413621, 21699341, 22142544, 22373051, 22688811, 23111424, 23161430, 23434063, 23794510, 24095551, 24163955, 24296281, 24451957, 24508634, 24793826, 25043550, 25313548, 25439757, 25747451, 26023059, 26199281, 26544541, 26611133, 26706327, 26943568, 27105291, 27304418, 27571604
Classification du dispositif
Hematology and Pathology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.
Description du dispositif
DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849 || Product Usage: Collection of cord blood
Manufacturer
DeRoyal Industries Inc
Language
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