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Smith & Nephew Medical, Ltd.

Last updated May 23, 2026

Information

Country: US
Address: —
Website: —
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Email: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (501)

Page 1 of 11

Device	Model / Reference	Registries	Class	Status
Opsite Post-Op Visible 35x10cm Ctn 20	66800141	FDA UDI	Class I	Active
Renasys	66801454	FDA UDI	Class II	Active
Cuticerin 7.5x7.5cm Ctn 50	66045560	FDA UDI	U	Active
Pico™ 7	66022020	FDA UDI	Class II	Active
REPLICaRE THIN DRESS 6X8IN	59484200	FDA UDI	Class I	Active
Exu-Dry Slit Tube 4x6in Ctn 25	5999101	FDA UDI	Class I	Active
Exu-Dry Slit Tube 2x3in Pkg50	5999PTM	FDA UDI	Class I	Active
Acticoat 7 2" X 2"	20341	FDA UDI	U	Active
RENaSYS G XL W/SOFT PORT	66800936	FDA UDI	Class II	Active
Pico 14	66022043	FDA UDI	Class II	Active
Biobrane	66027702	FDA UDI	U	Active
Iodoflex Dressing 3x10g USA	6602134010	FDA UDI	U	Active
Renasys	66020912	FDA UDI	Class II	Active
Versajet™ Ii	66800475	FDA UDI	Class II	Active
Pico™ 7	66002001	FDA UDI	Class II	Active
Allevyn Ag Non Adhesive 8x8" Ctn10	66020981	FDA UDI	U	Active
Pico™ 7	66022016	FDA UDI	Class II	Active
Durafiber 15x15 Ctn 5	66800561	FDA UDI	Class I	Active
Exu-Dry Leg/Foot Dressing Ctn 20	5999LPL	FDA UDI	Class I	Active
Pico™ 7	66022021	FDA UDI	Class II	Active
Opsite Incise 28x45cm Ctn 10	4988	FDA UDI	Class I	Active
ALLEVYN COMPLETE CARE L Rectangle 10cm x 30cm CTN 10	66807701	FDA UDI	Class I	Active
Pico™ 7	66002002	FDA UDI	Class II	Active
Leukostrip™	66002882	FDA UDI	Class I	Active
Pico	66021358	FDA UDI	Class II	Active
Renasys Touch	66801277	FDA UDI	Class II	Active
Versajet	66800039	FDA UDI	Class II	Active
Exu-Dry Adult Face Drsg Pk 20	5999FM1	FDA UDI	Class I	Active
Renasys	66801309	FDA UDI	Class II	Active
IV3000 FRAME 4"x4 3/4" NSB	59411200	FDA UDI	Class I	Active
Exu-Dry Drsg 15x18in Pkg 30	5999M18	FDA UDI	Class I	Active
Opsite Post-Op Visible 25x10cm Ctn 20	66800139	FDA UDI	Class I	Active
VERSAJET III Hydrosurgery System Foot Pedal	66802155	FDA UDI	Class II	Active
Iodosorb	6602124014	FDA UDI	U	Active
PROFORE LITE SYSTEM KIT Case 8	66000415	FDA UDI	Class I	Active
Acticoat 2"x2"	20601	FDA UDI	U	Active
Pico 14	66022045	FDA UDI	Class II	Active
Acticoat Flex3 4" X 8"	66800417	FDA UDI	U	Active
ALLEVYN Gentle Border Lite 7.5cm x 7.5cm	66020412	FDA UDI	Class I	Active
Leukostrip 4x38mm Ctn 50	66002876	FDA UDI	Class I	Active
Renasys Go Service Manual	66021206	FDA UDI	Class II	Active
Pico	66800953	FDA UDI	Class II	Active
Acticoat Flex7 8" X 16"	66800407	FDA UDI	U	Active
Pico™ 7	66002008	FDA UDI	Class II	Active
Acticoat 4" X 4"	20101	FDA UDI	U	Active
Renasys	66020961	FDA UDI	Class II	Active
Allevyn Life L 15.4x15.4 Ctn10	66801069	FDA UDI	Class I	Active
REPLICaRE 6X6IN (15X15CM)	483200	FDA UDI	Class I	Active
Renasys	66800912	FDA UDI	Class II	Active
Renasys G Large W/Soft Port	66020935	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 2, 2024	Z-0516-2025	—	open, classified	Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Mar 11, 2024	Z-1596-2024	—	open, classified	Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Mar 11, 2024	Z-1597-2024	—	open, classified	Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Smith & Nephew Medical Ltd HULL East Riding of Yorkshire · GB FEI 3002808194