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Activbraid

FDA UDI

Class II (US FDA UDI)

by Embody, Inc.

Identity

Trade Name
ACTIVBRAID FDA UDI
Generic Name
Collagen-polymer suture FDA UDI
Device Name
ACTIVBRAID Collagen-UHMWPE Co-Braid 2 Suture w/ 1/2c Taper Point Needle, Blue FDA UDI
Model / Reference
AB-200R-1B FDA UDI
Description
ACTIVBRAID Collagen-UHMWPE Co-Braid 2 Suture w/ 1/2c Taper Point Needle, Blue FDA UDI

Identifiers

Catalog Number
AB-200R-1B FDA UDI
Primary DI / UDI-DI
00810063820411 FDA UDI
510(k) Number
K223822 FDA UDI
FDA Product Code
GAT FDA UDI
GMDN Term
Collagen-polymer suture FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 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
MRI Safety
MR Safe FDA UDI

Category: Collagen-polymer suture

Activbraid by Embody, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Collagen-polymer suture.

Cleared under the same submission

K223822 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Embody, Inc.

Sources (1)

  • FDA UDI e7cb7fad-35de-427f-9b17-9df2b900757c 35 fields · synced Jun 6, 2026