FDA UDI
In Commercial Distribution
🇺🇸 United States
UTF Hip Stem
DI: 04719872156994
·
Model: 9106-6311-RA
·
UNITED ORTHOPEDIC CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UTF Hip Stem
- Primary DI
- 04719872156994
- Version / Model
- 9106-6311-RA
- Catalog Number
- 9106-6311-RA
- Company Name
- UNITED ORTHOPEDIC CORP.
- Labeler DUNS
- 656700556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-25
- Public Version
- 1
- Public Version Date
- 2018-07-26
- Public Version Status
- New
- Public Device Record Key
- c8734df9-ae98-4320-ab5d-958e079b4b48
Device Description
UTF Broach, reduced, ML 0mm, #11
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
- Yes
- 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 |
|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | 888.3390 | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36167 | Orthopaedic broach | A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719872156994 | GS1 |
Customer Contacts
- Phone
- +886229294567
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123550 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | reduced, ML 0mm, #11 |