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Renasys

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew Medical, Ltd.

Identity

Trade Name
Renasys FDA UDI
Generic Name
Negative-pressure wound therapy system canister FDA UDI
Device Name
Renasys EZ Max Quick Reference Guide US FDA UDI
Model / Reference
66021811 FDA UDI
Description
Renasys EZ Max Quick Reference Guide US FDA UDI

Identifiers

Catalog Number
66021811 FDA UDI
Primary DI / UDI-DI
00040565127293 FDA UDI
510(k) Number
K142979 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Negative-pressure wound therapy system canister FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Renasys by Smith & Nephew Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K142979 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew Medical, Ltd.

Sources (1)

  • FDA UDI c5751456-6c97-4d4b-b580-7a033788aa3f 36 fields · synced May 30, 2026