FDA UDI
In Commercial Distribution
🇺🇸 United States
QuadVantage
DI: 00850050146117
·
Model: 41001
·
Quadvantage Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QuadVantage
- Primary DI
- 00850050146117
- Version / Model
- 41001
- Catalog Number
- 41001
- Company Name
- Quadvantage Technology, Inc.
- Labeler DUNS
- 112134851
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-19
- Public Version
- 1
- Public Version Date
- 2023-06-27
- Public Version Status
- New
- Public Device Record Key
- f7a325ea-55e5-46e2-9504-b568237fb0bd
Device Description
QuadVantage Quadriceps Autograft Instrument Kit. Full set of re-usable instruments for performing a quadriceps autograft with or without a bone plug. Packaged in an 11” x 7” x 1.25” sterilization tray. Five Instruments included are the VariBlade UDI00850050146049, the QuadSabre UDI00850050146056, Saw Guide UDI00850050146032, Saw Guide UDI00850050146049 and the Cobra Harvester UDI00850050146063. Instruments are re-usable and must be sterilized per instructions provided by the referenced IFU found at quadvantage.com/IFU prior to use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44091 | Arthroscopic surgical procedure kit, non-medicated, reusable | A collection of various surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850050146117 | GS1 |
Customer Contacts
- Phone
- 18339396021
- [email protected]