FDA UDI
In Commercial Distribution
🇺🇸 United States
Stitch Cerclage - Suture Tapes
DI: 07899258696997
·
Model: 333-ECBR-25-1248CO
·
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Stitch Cerclage - Suture Tapes
- Primary DI
- 07899258696997
- Version / Model
- 333-ECBR-25-1248CO
- Company Name
- GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Labeler DUNS
- 900865213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-25
- Public Version
- 1
- Public Version Date
- 2025-09-02
- Public Version Status
- New
- Public Device Record Key
- d9b0b8fa-ed57-404b-a4f8-617cb64820a3
Device Description
STERNAL STITCH CERCLAGE - Suture Tape UHMWPE white 2,5mm with curved needle 1/2 48mm conventional tip
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
- Yes
- 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 |
|---|---|---|---|---|
| JDQ | Cerclage, Fixation | Orthopedic | 888.3010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46242 | Surgical support tape, non-bioabsorbable | A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07899258696997 | GS1 |