← Back to catalogue

Cap-Fix

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
CAP-FIX FDA UDI
Generic Name
Suturing unit, single-use FDA UDI
Device Name
CAP-FIX SUTURE PASSER 70 DEG FDA UDI
Model / Reference
72205684 FDA UDI
Description
CAP-FIX SUTURE PASSER 70 DEG FDA UDI

Identifiers

Catalog Number
72205684 FDA UDI
Primary DI / UDI-DI
00885556805398 FDA UDI
FDA Product Code
HWQ FDA UDI
GMDN Term
Suturing unit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Suturing unit, single-use

Cap-Fix by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suturing unit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Sources (1)

  • FDA UDI 068cf603-7360-413e-9cf5-c39893733cca 35 fields · synced Jun 8, 2026