FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Metha®
DI: 04046963183752
·
Model: NC089K
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Metha®
- Primary DI
- 04046963183752
- Version / Model
- NC089K
- Catalog Number
- NC089K
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-27
- Public Version
- 3
- Public Version Date
- 2018-06-28
- Public Version Status
- Update
- Public Device Record Key
- 50773828-e353-4a52-a2d8-9467e708646b
- Distribution End Date
- 2017-01-27
Device Description
METHA NECK 12/14 135°/7.5°L RETRO-R ANTE
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 |
|---|---|---|---|---|
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented | Orthopedic | 888.3360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59688 | Femoral head/stem prosthesis adaptor | A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046963183752 | GS1 |
Customer Contacts
- Phone
- +1(888)229-3002
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | CCD angle (°) : 135 / 7.5 | ||
| Device Size Text, specify | Taper Size : 12/14 |