FDA UDI
In Commercial Distribution
🇺🇸 United States
Full XPE cup
DI: 04711605573740
·
Model: 1302-3042
·
UNITED ORTHOPEDIC CORP.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Full XPE cup
- Primary DI
- 04711605573740
- Version / Model
- 1302-3042
- Catalog Number
- 1302-3042
- Company Name
- UNITED ORTHOPEDIC CORP.
- Labeler DUNS
- 656700556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-06
- Public Version
- 4
- Public Version Date
- 2018-08-08
- Public Version Status
- Update
- Public Device Record Key
- 57b4df92-4385-41a7-aa2d-a735ee2426ec
Device Description
Full XPE cup, ID 26mm, OD 42mm
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 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | 888.3350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34076 | Polyethylene acetabulum prosthesis | A sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of polyethylene (polyethylene cup); it may include fixation devices (e.g., screws) for attachment to the body. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04711605573740 | GS1 |
Customer Contacts
- Phone
- +886229294567
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163441 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | ID 26mm |