FDA UDI
In Commercial Distribution
🇺🇸 United States
FiberLocker Instrument
DI: 07649988202247
·
Model: FL516SNA
·
ZuriMED Technologies AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FiberLocker Instrument
- Primary DI
- 07649988202247
- Version / Model
- FL516SNA
- Company Name
- ZuriMED Technologies AG
- Labeler DUNS
- 480096456
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-10
- Public Version
- 2
- Public Version Date
- 2026-03-25
- Public Version Status
- Update
- Public Device Record Key
- d0ef8dba-8434-4dfb-b525-c6be2d0d3596
Device Description
ZuriMED Technologies AG - FiberLocker Instrument
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 |
|---|---|---|---|---|
| OWX | Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | General, Plastic Surgery | 878.3300 | 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 | 07649988202247 | GS1 | ||||
| Package | 17649988202244 | GS1 | Box | 11 | In Commercial Distribution |