FDA UDI
In Commercial Distribution
🇺🇸 United States
HammerTube™ System
DI: 00889795057693
·
Model: P40-001-0275-SK
·
PARAGON 28, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HammerTube™ System
- Primary DI
- 00889795057693
- Version / Model
- P40-001-0275-SK
- Catalog Number
- P40-001-0275-SK
- Company Name
- PARAGON 28, INC.
- Labeler DUNS
- 042961576
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-10
- Public Version
- 1
- Public Version Date
- 2023-02-20
- Public Version Status
- New
- Public Device Record Key
- 99649d35-f979-4e98-90d8-93b7298c4727
Device Description
HammerTube™ System Implant Kit, Ø2.75 x 14mm, 0°, Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61687 | Interphalangeal joint arthrodesis implant | A sterile implantable device designed to be inserted across a toe or finger interphalangeal joint, into the contiguous phalanges, to fuse the joint (arthrodesis), typically to correct joints damaged by traumatic, degenerative or rheumatoid arthritis, or other deformities (e.g., hammer toe), or for arthroplasty revision. It is made of metal [(e.g., stainless steel, nickel-titanium alloy (Nitinol)]) and can be of several geometric shapes (e.g., a small rod with barbs at each end, or X-shaped); devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889795057693 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171715 | 000 |