FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867348707
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1934BCT-2-1
Catalog number
AR-1934BCT-2-1
Device description
3.0MM BC SUTURETAK DL W/ SUTURETAPE
Published
2022-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAIFastener, fixation, biodegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867348707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867348707008888673487078888673487070888867348707

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867614956Arthrex®AR-S8457EXCAR-S8457EXC2026-05-25
00888867531949Arthrex®AR-8827H-22SAR-8827H-22S2026-03-16
00888867531970Arthrex®AR-8827H-28SAR-8827H-28S2026-03-16
00888867531987Arthrex®AR-8827H-30SAR-8827H-30S2026-03-16
00888867532014Arthrex®AR-8827H-36SAR-8827H-36S2026-03-16
00888867134874Arthrex®AR-9104-04AR-9104-042017-02-15
00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13
00888867336520Arthrex®AR-1593DAR-1593D2019-12-13
00888867310209Arthrex®AR-4158TAR-4158T2019-11-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867561687Arthrex®ARTHREX, INC.MAI2026-03-17
00888867561694Arthrex®ARTHREX, INC.MAI2026-03-17
00888867561700Arthrex®ARTHREX, INC.MAI2026-03-17
06438394007376ActivaScrew™ InterferenceBioretec OyMAI2026-02-05
06438394007406ActivaScrew™ InterferenceBioretec OyMAI2026-02-05
06438394007413ActivaScrew™ InterferenceBioretec OyMAI2026-02-05
06438394007420ActivaScrew™ InterferenceBioretec OyMAI2026-02-05
06438394007444ActivaScrew™ InterferenceBioretec OyMAI2026-02-05
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06438394007505ActivaScrew™ InterferenceBioretec OyMAI2026-02-05
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06438394007536ActivaScrew™ InterferenceBioretec OyMAI2026-02-05
06438394007543ActivaScrew™ InterferenceBioretec OyMAI2026-02-05
06438394007550ActivaScrew™ InterferenceBioretec OyMAI2026-02-05
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06438394007437ActivaScrew™ InterferenceBioretec OyMAI2026-01-27
06438394007468ActivaScrew™ InterferenceBioretec OyMAI2026-01-27
06438394007475ActivaScrew™ InterferenceBioretec OyMAI2026-01-27
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06438394007512ActivaScrew™ InterferenceBioretec OyMAI2026-01-27
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06438394007390ActivaScrew™ InterferenceBioretec OyMAI2026-01-25
06438394007451ActivaScrew™ InterferenceBioretec OyMAI2026-01-25