FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867337336
Brand
Arthrex®
Company
ARTHREX, INC.
Model
ABS-2020-OT
Catalog number
ABS-2020-OT
Device description
IOBP FOOT AND ANKLE PROCEDURE KIT
Published
2020-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867337336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867337336008888673373368888673373360888867337336

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

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
true
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
00810126506757Comfortox3D DENTAL DESIGNS AND DEVELOPMENT, LLCFMF2026-03-24
00810126506764Comfortox3D DENTAL DESIGNS AND DEVELOPMENT, LLCFMF2026-03-24
18699207302025Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207305033Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207310037Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207311003Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207320029Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207350026Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
04046955850839Omnifix®B. BRAUN MEDICAL INC.FMF2026-03-08
18800109007035DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
18800109007073DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
18800109007127DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
00849296013345WelmedWELMED INC.FMF2026-02-15
00849296013352WelmedWELMED INC.FMF2026-02-15
00849296013369WelmedWELMED INC.FMF2026-02-15
00849296013376WelmedWELMED INC.FMF2026-02-15
00849296013383WelmedWELMED INC.FMF2026-02-15
00849296013390WelmedWELMED INC.FMF2026-02-15
00849296013406WelmedWELMED INC.FMF2026-02-15
00849296013413WelmedWELMED INC.FMF2026-02-15
00849296013420WelmedWELMED INC.FMF2026-02-15
00849296013437WelmedWELMED INC.FMF2026-02-15
00849296013444WelmedWELMED INC.FMF2026-02-15
00849296013451WelmedWELMED INC.FMF2026-02-15
00849296013468WelmedWELMED INC.FMF2026-02-15
00849296013475WelmedWELMED INC.FMF2026-02-15
00849296013482WelmedWELMED INC.FMF2026-02-15
00849296013499WelmedWELMED INC.FMF2026-02-15
00849296013505WelmedWELMED INC.FMF2026-02-15
20850083784007Comfort EZS.D.I. USA, INC.FMF2026-02-13