FDA UDI
In Commercial Distribution
🇺🇸 United States
Cermet Series III
DI: 05051693311084
·
Model: 10 Deg. Hood Acetabular Liner 54/56 x 44mm - 32mm Head
·
IMPLANTS INTERNATIONAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cermet Series III
- Primary DI
- 05051693311084
- Version / Model
- 10 Deg. Hood Acetabular Liner 54/56 x 44mm - 32mm Head
- Catalog Number
- AL3835
- Company Name
- IMPLANTS INTERNATIONAL LTD
- Labeler DUNS
- 346627222
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-31
- Public Version
- 3
- Public Version Date
- 2024-04-08
- Public Version Status
- Update
- Public Device Record Key
- 539f0363-d7cd-46ed-9d03-072924068147
Device Description
Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) 10 Deg. Hood 54/56 x 44mm
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44362 | 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 may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051693311084 | GS1 |
Customer Contacts
- Phone
- +4401642769080
- [email protected]
- Phone
- +4401642769080
- [email protected]
- Phone
- +4401642769080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071583 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 56 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room temperature and Dry