FDA UDI
In Commercial Distribution
🇺🇸 United States
ACTIVBRAID
DI: 00810063820428
·
Model: AB-150T-1W
·
Embody, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACTIVBRAID
- Primary DI
- 00810063820428
- Version / Model
- AB-150T-1W
- Catalog Number
- AB-150T-1W
- Company Name
- Embody, Inc.
- Labeler DUNS
- 079544913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-31
- Public Version
- 3
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 3387d7fa-dcc8-4c22-b8ec-3e0123f089e2
Device Description
ACTIVBRAID Collagen-UHMWPE Co-Braid 1.5mm Suture Tape w/ 1/2c Taper Point Needle, White/Black
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 |
|---|---|---|---|---|---|---|
| Primary | 00810063820428 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223822 | 000 |