FDA UDI
In Commercial Distribution
🇺🇸 United States
ANSER Clavicle Pin
DI: 08720629950600
·
Model: ANSER Tray
·
Baat Medical Products B.V.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ANSER Clavicle Pin
- Primary DI
- 08720629950600
- Version / Model
- ANSER Tray
- Catalog Number
- ANS-701
- 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
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- cfcf9710-5567-474a-94e2-18a4823e7346
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 fixation rod | A small-diameter implantable rod intended to be used for the fixation of a bone fracture or bone grafts, an osteotomy, or an arthrodesis, in the presence of additional immobilization, typically to treat midshaft fractures, nonunions, and malunions of the clavicle bone. Commonly referred to as a pin, it is typically partially-threaded and may be fitted with a securing nut and is capable of being fitted into the intramedullary canal of the clavicle through a small incision. It is typically made of surgical stainless steel. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08720629950600 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201830 | 000 |