ActivBraid
- Primary DI
- 00810063820602
- Brand
- ActivBraid
- Company
- Embody, Inc.
- Model
- AB-021R-2B
- Device description
- ActivBraid 2-0 Collagen-UHMWPE Co-Braid Suture with 26mm 1/2c Taper Point Needle, Blue, 18” (45.7cm)
- Published
- 2025-10-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K223822 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10810063820609 | Package | GS1 | 12 | In Commercial Distribution |
| 00810063820602 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10810063820609 | 10810063820609 | ||
| 00810063820602 | 00810063820602 | 810063820602 | 0810063820602 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Regulatory Flags#
- DUNS number
- 079544913
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00810063820459 | TAPESTRY Biointegrative Implant with Introducer | TR-2626-21 | TR-2626-21 | 2023-09-21 |
| 00810063820466 | TAPESTRY Biointegrative Implant with Introducer | TR-2626-31 | TR-2626-31 | 2023-09-21 |
| 00810063820039 | Tapestry Biointegrative Implant | TP-2030-01 | 2023-05-11 | |
| 00810063820077 | Tapestry Biointegrative Implant | TS-4030-02 | 2023-05-11 | |
| 00810063820169 | Embody Cannula | EM-A001-01 | EM-A001-01 | 2022-06-02 |
| 00810063820176 | Embody Cannula | EM-A002-01 | EM-A002-01 | 2022-06-02 |
| 00810063820183 | Embody Cannula | EM-A003-01 | EM-A003-01 | 2022-06-02 |
| 00810063820107 | TAPESTRY Biointegrative Implant with Introducer | TR-3030-21 | TR-3030-21 | 2022-06-01 |
| 00810063820138 | TAPESTRY Biointegrative Implant with Introducer | TR-3030-31 | TR-3030-31 | 2022-06-01 |
| 00810063820060 | TAPESTRY Biointegrative Implant | TS-5040-02 | 2021-04-01 | |
| 00810063820008 | TAPESTRY BIointegrative Implant with Insertion Sleeve | TP-7050-02 | 2020-11-20 | |
| 00810063820015 | TAPESTRY Biointegrative Implant | TP-7025-02 | 2020-11-20 | |
| 00810063820022 | TAPESTRY Biointegrative Implant | TP-2550-01 | TP-2550-01 | 2020-11-20 |
| 00810063820046 | TAPESTRY Biointegrative Implant | TP-3030-01 | 2020-11-20 | |
| 00810063820053 | TAPESTRY Biointegrative Implant | TP-4030-01 | 2020-11-20 | |
| 00810063820381 | ACTIVBRAID | AB-021R-1B | AB-021R-1B | 2023-08-31 |
| 00810063820398 | ACTIVBRAID | AB-250T-0W | AB-250T-0W | 2023-08-31 |
| 00810063820404 | ACTIVBRAID | AB-200R-1W | AB-200R-1W | 2023-08-31 |
| 00810063820411 | ACTIVBRAID | AB-200R-1B | AB-200R-1B | 2023-08-31 |
| 00810063820428 | ACTIVBRAID | AB-150T-1W | AB-150T-1W | 2023-08-31 |
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