← Back to catalogue

A-dec

FDA UDI

Class I (US FDA UDI)

by A-Dec, Inc.

Identity

Trade Name
A-dec FDA UDI
Generic Name
Barbed polyolefin suture FDA UDI
Device Name
Electric LS Package,M20L,Master Matic,OTC FDA UDI
Model / Reference
54.0865.00 FDA UDI
Description
Electric LS Package,M20L,Master Matic,OTC FDA UDI

Identifiers

Catalog Number
54.0865.00 FDA UDI
Primary DI / UDI-DI
10194665004460 FDA UDI
510(k) Number
K143465 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Barbed polyolefin suture FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Barbed polyolefin suture

A-dec by A-Dec, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Barbed polyolefin suture.

Cleared under the same submission

K143465 also covers:

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

Manufacturer
A-Dec, Inc.

Sources (1)

  • FDA UDI 8105b116-65ed-4247-8709-aeefa258b249 35 fields · synced Jun 8, 2026