FDA.reportPublic FDA data

QuadVantage

Primary DI
00850050146094
Brand
QuadVantage
Company
Quadvantage Technology, Inc.
Model
41005
Catalog number
41005
Device description
QuadVantage 10mm Disposable Blade Set. One blade Kit is used per surgery/ case and then disposed of. Blades included are intended to be used with the QuadVanatage Cobra Harvester (UDI 00850050146063) and the QuadSabre (UDI 00850050146056)
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTSKnife, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTSKnife, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050146094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050146094008500501460948500501460940850050146094

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18339396021tom@quadvantageinc.com

Regulatory Flags#

DUNS number
112134851
Device count
1
Premarket exempt
true
Kit
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
00850050146063QuadVantage31001310012023-06-19
00850050146070QuadVantage41003410032023-06-19
00850050146087QuadVantage41004410042023-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974940307236endophixSuzhou Endophix Co., Ltd.HTS2026-06-23
20653405990366Infinity™Conmed CorporationHTS2026-06-10
20653405990373Infinity™Conmed CorporationHTS2026-06-10
20653405990380Infinity™Conmed CorporationHTS2026-06-10
20653405990397Infinity™Conmed CorporationHTS2026-06-10
20653405990403Infinity™Conmed CorporationHTS2026-06-10
20653405990410Infinity™Conmed CorporationHTS2026-06-10
00192896122796McIlwraith Bistouri KnifeSONTEC INSTRUMENTS, INC.HTS2026-03-10
00853508002645BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-03-02
00853508002539BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-02-16
00840967154527SigmaALPHATEC SPINE, INC.HTS2025-07-23
00192896121560Arthroscopic Bayonet KnifeSONTEC INSTRUMENTS, INC.HTS2025-05-14
10888277392687MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-04-17
00853508002621BESTLacey Manufacturing Company, LLCHTS2025-03-25
10080196392582MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-22
10080196392636MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392643MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392667MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392564MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392571MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392588MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392595MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392601MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392618MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392625MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392632MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392649MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392656MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392663MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392670MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21