FDA UDI
In Commercial Distribution
🇺🇸 United States
Paragon
DI: 09340499024516
·
Model: GM08001-323-00
·
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Paragon
- Primary DI
- 09340499024516
- Version / Model
- GM08001-323-00
- Catalog Number
- GM08001-323-00
- Company Name
- GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
- Labeler DUNS
- 752039982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 4
- Public Version Date
- 2018-12-07
- Public Version Status
- Update
- Public Device Record Key
- 02f013dc-f771-4004-a6a5-f2069b4e1332
Device Description
Paragon Slap Hammer Adaptor
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 |
|---|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate | Orthopedic | 888.3353 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47779 | Orthopaedic instrument surgical connector | A small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09340499024516 | GS1 |
Customer Contacts
- Phone
- +6128870100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123782 | 000 |