FDA.report

Arthrex®

Primary DI
10888867020587
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1662BC-8
Catalog number
AR-1662BC-8
Device description
SWVLK TENO BIO-COMP 8X 19.5MM
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Product Code Classifications

CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888867020587PrimaryGS10
M150AR1662BC81SecondaryHIBCC0
00888867020580Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886702058710888867020587
00888867020580008888670205808888670205800888867020580

GMDN Terms

TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags

DUNS number
131747628
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00888867561687Arthrex®AR-2600FSF-1AR-2600FSF-12026-03-17
00888867561694Arthrex®AR-2600FSF-2AR-2600FSF-22026-03-17
00888867561700Arthrex®AR-2600FSF-3AR-2600FSF-32026-03-17
00888867463363Arthrex®AR-8974-02AR-8974-022026-03-16
00888867519459Arthrex®AR-8974FCAR-8974FC2026-03-16
00888867519473Arthrex®AR-8974FCLAR-8974FCL2026-03-16
00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
00888867519510Arthrex®AR-8974TLAR-8974TL2026-03-16
00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
00888867529052Arthrex®AR-8827H-14AR-8827H-142026-03-16
00888867529069Arthrex®AR-8827H-16AR-8827H-162026-03-16
00888867529076Arthrex®AR-8827H-18AR-8827H-182026-03-16
00888867529083Arthrex®AR-8827H-20AR-8827H-202026-03-16
00888867529090Arthrex®AR-8827H-22AR-8827H-222026-03-16
00888867529106Arthrex®AR-8827H-24AR-8827H-242026-03-16
00888867529113Arthrex®AR-8827H-26AR-8827H-262026-03-16
00888867529120Arthrex®AR-8827H-28AR-8827H-282026-03-16
00888867529137Arthrex®AR-8827H-30AR-8827H-302026-03-16
00888867529144Arthrex®AR-8827H-32AR-8827H-322026-03-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888867561687Arthrex®ARTHREX, INC.MAI2026-03-17
00888867561694Arthrex®ARTHREX, INC.MAI2026-03-17
00888867561700Arthrex®ARTHREX, INC.MAI2026-03-17
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