FDA UDI
In Commercial Distribution
🇺🇸 United States
COPTOS TH
DI: 03662200005536
·
Model: COPTOS 45 TH
·
SOC ETUDES RECHERCHES FABRICATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- COPTOS TH
- Primary DI
- 03662200005536
- Version / Model
- COPTOS 45 TH
- Company Name
- SOC ETUDES RECHERCHES FABRICATION
- Labeler DUNS
- 282651413
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-01
- Public Version
- 4
- Public Version Date
- 2026-03-09
- Public Version Status
- Update
- Public Device Record Key
- 00412569-e6b8-43a9-8be5-49cc255e04ba
Device Description
NOVAE Dual Mobility Acetabular Cup - COPTOS TH revision metal-back cementless COPTOS TH has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook)
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| 43167 | Acetabular shell | An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03662200005536 | GS1 |