Identity
- Trade Name
- ACTIVBRAID FDA UDI
- Generic Name
- Collagen-polymer suture FDA UDI
- Device Name
- ACTIVBRAID Collagen-UHMWPE Co-Braid 1.5mm Suture Tape w/ 1/2c Taper Point Needle, White/Black FDA UDI
- Model / Reference
- AB-150T-1W FDA UDI
- Description
- ACTIVBRAID Collagen-UHMWPE Co-Braid 1.5mm Suture Tape w/ 1/2c Taper Point Needle, White/Black FDA UDI
Identifiers
- Catalog Number
- AB-150T-1W FDA UDI
- Primary DI / UDI-DI
- 00810063820428 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
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.
- ACTIVBRAID — Embody, Inc. · Class II
- ACTIVBRAID — Embody, Inc. · Class II
- ACTIVBRAID — Embody, Inc. · Class II
- ACTIVBRAID — Embody, Inc. · Class II
- ACTIVBRAID — Embody, Inc. · Class II
- ACTIVBRAID — Embody, Inc. · Class II
Cleared under the same submission
K223822 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Embody, Inc.
Sources (1)
- FDA UDI 3387d7fa-dcc8-4c22-b8ec-3e0123f089e2 35 fields · synced May 30, 2026