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Bioinductive Implant with Arthroscopic Delivery System - Medium

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Bioinductive Implant with Arthroscopic Delivery System - Medium FDA UDI
Generic Name
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Model / Reference
4397 FDA UDI

Identifiers

Catalog Number
4397 FDA UDI
Primary DI / UDI-DI
00854501006142 FDA UDI
FDA Product Code
OWY FDA UDI
ORQ FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Bioinductive Implant with Arthroscopic Delivery System - Medium by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI b29f6bdc-6aa6-45d7-bec6-752002e94b61 33 fields · synced Jun 8, 2026