FDA UDI
In Commercial Distribution
🇺🇸 United States
PUMA SYSTEM
DI: B671FA0017B0
·
Model: GEN 3
·
PANTHER ORTHOPEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PUMA SYSTEM
- Primary DI
- B671FA0017B0
- Version / Model
- GEN 3
- Company Name
- PANTHER ORTHOPEDICS, INC.
- Labeler DUNS
- 117139687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-13
- Public Version
- 1
- Public Version Date
- 2020-02-21
- Public Version Status
- New
- Public Device Record Key
- 1a4b9de8-b02d-4597-936d-c0d563c2d22b
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTN | Washer, Bolt Nut | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16077 | Orthopaedic bone bolt | A short rod or shaft designed to be inserted through a long bone in order to secure the bone for traction or for a similar process/apparatus. The device is fastened with a nut/washer, and is typically made of metal or a polymer. It is typically used in the proximal tibia or distal femur. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B671FA0017B0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171703 | 000 |