FDA UDI
In Commercial Distribution
🇺🇸 United States
Phantom Hindfoot TTC/TC Nail System
DI: 00889795111432
·
Model: P32-270-1254-S
·
Paragon 28, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phantom Hindfoot TTC/TC Nail System
- Primary DI
- 00889795111432
- Version / Model
- P32-270-1254-S
- Catalog Number
- P32-270-1254-S
- Company Name
- Paragon 28, Inc.
- Labeler DUNS
- 042961576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-19
- Public Version
- 1
- Public Version Date
- 2025-11-27
- Public Version Status
- New
- Public Device Record Key
- 03bf28fd-47e6-4ea9-9220-fad3ab8332fd
Device Description
Phantom Curved Nail, 12.5 X 140mm (Sterile)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44854 | Arthrodesis intramedullary nail, non-distracting | A rigid rod, not intended for bone distraction, dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), fibula, radius, ulna] which extends beyond the joint to an adjacent bone(s), as part of traumatic repair or reconstructive procedures. It may be of fixed or variable length to allow compression (dynamic). It is intended to be fixed to the bone with screws which may be included with the nail. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889795111432 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210869 | 000 |