FDA UDI
In Commercial Distribution
🇺🇸 United States
Alliant Biotech
DI: G611220811102000
·
Model: 10x200
·
MEDISURGE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alliant Biotech
- Primary DI
- G611220811102000
- Version / Model
- 10x200
- Catalog Number
- 22-08-1110200
- Company Name
- MEDISURGE LLC
- Labeler DUNS
- 119198202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-02
- Public Version
- 1
- Public Version Date
- 2024-08-12
- Public Version Status
- New
- Public Device Record Key
- 80f2f747-bb6b-4782-a4f0-130a8590f05b
Device Description
Symmetric Total Knee Coated Revision Stem Size 10x200
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48066 | Knee femur stem prosthesis | A sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G611220811102000 | HIBCC |
Customer Contacts
- Phone
- 8883071144
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100370 | 000 |