FDA UDI
In Commercial Distribution
🇺🇸 United States
VEGA
DI: 04046964760419
·
Model: MG961R
·
AESCULAP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VEGA
- Primary DI
- 04046964760419
- Version / Model
- MG961R
- Catalog Number
- MG961R
- Company Name
- AESCULAP, INC.
- Labeler DUNS
- 082594540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-16
- Public Version
- 3
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- cd9cb3d6-db41-4e75-98a5-fb7ebc9a458d
Device Description
F1 4-IN-1 FEMUR CUTTING GUIDE
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZX | Guide, surgical, instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58387 | Surgical cutting/shaping board, reusable | A stiff, plastic device intended to be used as a surface to trim/contour objects or tissues (e.g., implants, transplants) in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations as a visual approximation aid. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964760419 | GS1 |
Customer Contacts
- Phone
- +1(888)229-3002
- [email protected]