FDA UDI
In Commercial Distribution
🇺🇸 United States
Paragon
DI: 09340499002163
·
Model: GM08001-208-03
·
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Paragon
- Primary DI
- 09340499002163
- Version / Model
- GM08001-208-03
- Catalog Number
- GM08001-208-03
- 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
- 2015-11-12
- Public Version
- 4
- Public Version Date
- 2021-07-09
- Public Version Status
- Update
- Public Device Record Key
- 97de8997-e725-42d5-a0c0-2fc1caa8abb5
Device Description
Paragon Stem High Offset Sz 3 HA
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 |
|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55834 | Press-fit hip femur prosthesis, one-piece | A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is one-piece and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09340499002163 | GS1 |
Customer Contacts
- Phone
- +6128870100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123782 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Sz 3 High Offset |