FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Acetabular Hip System with ECiMa Liners
DI: 05055343869987
·
Model: 322.04.728
·
CORIN LTD
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trinity Acetabular Hip System with ECiMa Liners
- Primary DI
- 05055343869987
- Version / Model
- 322.04.728
- Catalog Number
- 322.04.728
- Company Name
- CORIN LTD
- Labeler DUNS
- 295437313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-17
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0f6ee2d4-83fd-4d22-b182-9316f117af9d
Device Description
Trinity Liner (ECIMA) Ø28mm +4mm Offset Taper Size 4
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
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
| OQI | Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, 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 |
|---|---|---|---|---|
| 43168 | Non-constrained polyethylene acetabular liner | A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055343869987 | GS1 |
Customer Contacts
- Phone
- +441285659866 ext. 2118
- [email protected]
- Phone
- +441285659866 ext. 2203
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111481 | 000 |