FDA.reportPublic FDA data

QuadVantage

Primary DI
00850050146063
Brand
QuadVantage
Company
Quadvantage Technology, Inc.
Model
31001
Catalog number
31001
Device description
QuadVantage COBRA Harvester - Re-usable instrument used to harvest/ shape the full length of the quadriceps graft prior to separating it from the quadriceps tendon. Uses disposable blades supplied separately.
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050146063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050146063008500501460638500501460630850050146063

GMDN Terms#

Term, Definition table
TermDefinition
Tendon stripperA hand-held manual surgical instrument designed to excise a length of ligament, tendon or fascia for use as a living graft. It typically consists of a handle and a semicircular shaped trough that terminates in a sharp cutting edge. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-833-939-6021tom@quadvantageinc.com

Regulatory Flags#

DUNS number
112134851
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850050146117QuadVantage41001410012023-06-19
00850050146018QuadVantage41008410082023-06-19
00850050146025QuadVantage31006310062023-06-19
00850050146032QuadVantage31005310052023-06-19
00850050146049QuadVantage31003310032023-06-19
00850050146056QuadVantage31004310042023-06-19
00850050146070QuadVantage41003410032023-06-19
00850050146087QuadVantage41004410042023-06-19
00850050146094QuadVantage41005410052023-06-19

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