FDA UDI
In Commercial Distribution
🇺🇸 United States
U2 Hip Stem
DI: 04719872167136
·
Model: 9104-6380
·
UNITED ORTHOPEDIC CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- U2 Hip Stem
- Primary DI
- 04719872167136
- Version / Model
- 9104-6380
- Catalog Number
- 9104-6380
- Company Name
- UNITED ORTHOPEDIC CORP.
- Labeler DUNS
- 656700556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-20
- Public Version
- 1
- Public Version Date
- 2018-07-23
- Public Version Status
- New
- Public Device Record Key
- b51d999d-aada-42e4-866a-d8c42b64c17c
Device Description
Revision hip stem broach, Ø16.5mm
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 |
|---|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | 888.3360 | 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 | 04719872167136 | GS1 |
Customer Contacts
- Phone
- +886229294567
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062978 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Ø16.5mm |