FDA UDI
In Commercial Distribution
🇺🇸 United States
BiMobile
DI: 04026575174744
·
Model: 184-260/08
·
WALDEMAR LINK GmbH & Co. KG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BiMobile
- Primary DI
- 04026575174744
- Version / Model
- 184-260/08
- Catalog Number
- 184-260/08
- Company Name
- WALDEMAR LINK GmbH & Co. KG
- Labeler DUNS
- 315675488
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-24
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- a7afe9de-0deb-447a-8c2e-cc01dfb2cf35
Device Description
BiMobile Liner - conventional UHMWPE
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
- 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, calcium 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 | 04026575174744 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171273 | 000 |