FDA UDI
In Commercial Distribution
🇺🇸 United States
ActivBraid
DI: 00810063820633
·
Model: AB-150T-0W
·
Embody, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ActivBraid
- Primary DI
- 00810063820633
- Version / Model
- AB-150T-0W
- Company Name
- Embody, Inc.
- Labeler DUNS
- 079544913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-28
- Public Version
- 1
- Public Version Date
- 2025-11-05
- Public Version Status
- New
- Public Device Record Key
- 12c3f112-0c18-45e9-a576-bdaa873ad3d4
Device Description
ActivBraid 1.5mm Collagen-UHMWPE Co-Braid Suture Tape, White/Black, 36” (91.5cm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 878.5000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66986 | Collagen-polymer suture | A multiple-strand (multifilament) thread made from strands of both a natural, bioabsorbable collagen derived from animals (e.g., sheep or bovine intestines) and non-bioabsorbable polymer [e.g., polyethylene (PE)], intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (includes use in orthopaedic surgeries). It may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810063820630 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00810063820633 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223822 | 000 |