FDA UDI
In Commercial Distribution
🇺🇸 United States
ANSER Clavicle Pin
DI: 08720629950587
·
Model: ANSER Lat. Fix. Device Inserter
·
Baat Medical Products B.V.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ANSER Clavicle Pin
- Primary DI
- 08720629950587
- Version / Model
- ANSER Lat. Fix. Device Inserter
- Catalog Number
- ANS-604
- Company Name
- Baat Medical Products B.V.
- Labeler DUNS
- 413205480
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-14
- Public Version
- 3
- Public Version Date
- 2025-02-06
- Public Version Status
- Update
- Public Device Record Key
- 0ed5ff60-76d3-4203-8f97-af1324579cbb
Device Description
ANSER Instruments
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
| JDW | Pin, Fixation, Threaded | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46865 | Clavicle intramedullary nail-like rod | A rod intended to be implanted into the intramedullary canal of the clavicle bone for the fixation of a fracture(s) and/or treatment of malunion(s)/nonunion(s). Also referred to as a nail or pin, it may be straight, curved or bendable, and might be partially-threaded, stabilised with a bone screw, and/or incorporate expandable hook-like features for stabilisation; it is typically made of stainless steel. Devices intended to assist with stabilisation (e.g., a bone screw) may be included with the rod. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08720629950587 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201830 | 000 |