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Renasys Go

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew Medical, Ltd.

Identity

Trade Name
RENASYS GO FDA UDI
Generic Name
Medical bag FDA UDI
Device Name
RENASYS GO CARRY BAG FDA UDI
Model / Reference
66800162 FDA UDI
Description
RENASYS GO CARRY BAG FDA UDI

Identifiers

Catalog Number
66800162 FDA UDI
Primary DI / UDI-DI
05000223465186 FDA UDI
510(k) Number
K152163 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Medical bag FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical bag

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

Similar devices

Also classified as Medical bag.

Cleared under the same submission

K152163 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 43ff7260-b7b1-4284-993a-576ee876639f 35 fields · synced May 30, 2026