FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867020016
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1606V
Catalog number
AR-1606V
Device description
STAR SLEEVE, VELCRO
Published
2018-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQZCOMPONENT, TRACTION, NON-INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888867020013PackageGS16In Commercial Distribution
00888867020016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886702001310888867020013
00888867020016008888670200168888670200160888867020016

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic casting standA structure/frame designed to hold and support a patient's torso or limb (arm or leg) in an appropriate position during an orthopaedic casting procedure. It typically consists of an adjustable base/pedestal and frame with a set of detachable components including limb-positioning attachments to maintain optimum joint alignment, supports for resting limbs, and blades for forming the cast. Typically the body part is placed on a blade and the cast material is wrapped around it; after completing the cast, the blade is removed from the cast to provide space for improved blood circulation and patient comfort. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867543904Arthrex®AR-1101TH-13CT-SAR-1101TH-13CT-S2026-09-25
00888867543911Arthrex®AR-1101TH-8CT-SAR-1101TH-8CT-S2026-09-25
00888867543928Arthrex®AR-1101TH-13OT-SAR-1101TH-13OT-S2026-09-25
00888867543935Arthrex®AR-1101TH-8OT-SAR-1101TH-8OT-S2026-09-25
00888867460973Arthrex®AR-9001A-7140CSAR-9001A-7140CS2026-06-11
00888867291690Arthrex®AR-3350-4031AR-3350-40312018-12-13
00888867291751Arthrex®AR-3355-4031AR-3355-40312018-12-13
00888867161085Arthrex®AR-3350-4071AR-3350-40712018-12-13
00888867161207Arthrex®AR-3355-4071AR-3355-40712018-12-13
00888867504059Arthrex®AR-9650CAR-9650C2026-09-21
00888867504066Arthrex®AR-9650C-01AR-9650C-012026-09-21
00888867504073Arthrex®AR-9650C-02AR-9650C-022026-09-21
00888867570764Arthrex®AR-9650SFL-10256AR-9650SFL-102562026-09-21
00888867570771Arthrex®AR-9650SFL-11250AR-9650SFL-112502026-09-21
00888867550292Arthrex®AR-6533S-STAR-6533S-ST2026-09-18
00888867550308Arthrex®AR-6533S-XLAR-6533S-XL2026-09-18
00888867550315Arthrex®AR-6534S-STAR-6534S-ST2026-09-18
00888867550322Arthrex®AR-6534S-XLAR-6534S-XL2026-09-18
00888867550339Arthrex®AR-6533S-STSAR-6533S-STS2026-09-18
00888867550346Arthrex®AR-6533S-XLSAR-6533S-XLS2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423797MillenniumAvalign Technologies, Inc.KQZ2026-08-07
00810075281675BoneFoamBONE FOAM, INC.KQZ2026-07-28
00810075281668BoneFoamBONE FOAM, INC.KQZ2026-06-12
00844107000804QuikBow Arbutus Medical IncKQZ2026-04-28
00848340016806ALLENHILL-ROM, INC.KQZ2026-04-24
00888867484986Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485099Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485105Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485112Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867484983Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485096Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485102Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485119Arthrex®ARTHREX, INC.KQZ2025-12-10
00810075281521BoneFoamBONE FOAM, INC.KQZ2025-08-15
00810075281491BoneFoamBONE FOAM, INC.KQZ2025-08-15
00810075281514BoneFoamBONE FOAM, INC.KQZ2025-08-15
00888867502710Arthrex®ARTHREX, INC.KQZ2025-08-14
10888867502717Arthrex®ARTHREX, INC.KQZ2025-08-14
20845854082925Paradigm RevolutionConmed CorporationKQZ2023-06-13
20845854082932Paradigm RevolutionConmed CorporationKQZ2023-06-13
0078755101165490403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
00787551011678NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
2078755101165890403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
20787551011672NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
00816342020718Accessories, arthroscopicPARCUS MEDICAL LLCKQZ2022-12-06
00842331141027Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331143373Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331136627Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-10
00610570001712"100 FT. 3/16"" TRACTION CORD"Bird & Cronin, LLCKQZ2022-08-20
00610570001750"1500 FT. 3/16"" TRACTION CORD"Bird & Cronin, LLCKQZ2022-08-20