FDA UDI
In Commercial Distribution
🇺🇸 United States
Phantom Hindfoot TTC/TC Nail System
DI: 00889795097972
·
Model: P31-955-1550
·
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
- 00889795097972
- Version / Model
- P31-955-1550
- Catalog Number
- P31-955-1550
- Company Name
- PARAGON 28, INC.
- Labeler DUNS
- 042961576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-15
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- d3480976-243d-4523-8119-7ea5363024a2
Device Description
Phantom Hindfoot Ball Tipped Guide Rod, 3.0 x 550mm
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 Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HXI | PASSER, WIRE, ORTHOPEDIC | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62729 | Orthopaedic guidewire, single-use | A thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889795097972 | GS1 |