FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vitelene®
DI: 04046963973360
·
Model: NV189E
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Vitelene®
- Primary DI
- 04046963973360
- Version / Model
- NV189E
- Catalog Number
- NV189E
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-26
- Public Version
- 5
- Public Version Date
- 2025-11-13
- Public Version Status
- Update
- Public Device Record Key
- c822baef-72c1-4293-835b-eb18331d4954
- Distribution End Date
- 2025-01-22
Device Description
VITELENE INSERT C 28MM SYM.
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 |
|---|---|---|---|---|
| OQG | Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented | Orthopedic | 888.3358 | 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 | 04046963973360 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Inner diameter (mm) : 28.000 MM | ||
| Device Size Text, specify | Figure/Size : Fig. C |