FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867387249
Brand
Arthrex®
Company
ARTHREX, INC.
Model
ABS-10062-TH13OT
Catalog number
ABS-10062-TH13OT
Device description
13G OPEN TIP BMA KIT
Published
2022-01-13
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
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867387249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867387249008888673872498888673872490888867387249

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy procedure kitA packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. 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
Kit
true
Lot or batch
true
Expiration date on label
true

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
00888867340183Arthrex®AR-D8400EXAR-D8400EX2019-10-06
00888867504288Arthrex®AR-9953AR-05AR-9953AR-052026-05-21
00888867504295Arthrex®AR-9953AR-03AR-9953AR-032026-05-21
00888867504318Arthrex®AR-9953AR-07AR-9953AR-072026-05-21
00888867504356Arthrex®AR-9953AR-09AR-9953AR-092026-05-21
00888867504363Arthrex®AR-9953AR-11AR-9953AR-112026-05-21
00888867504387Arthrex®AR-9953AR-13AR-9953AR-132026-05-21
00888867504394Arthrex®AR-9953AL-13AR-9953AL-132026-05-21
00888867504400Arthrex®AR-9953AR-15AR-9953AR-152026-05-21
00888867504417Arthrex®AR-9953AL-15AR-9953AL-152026-05-21
00888867504424Arthrex®AR-9953AR-03SAR-9953AR-03S2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033860001926BIOPSYBELL SRLBIOPSYBELL SRLKNW2023-10-23
08033860000141BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000189BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000240BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000264BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000448BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000462BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000547BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000585BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860001087BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860002664BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860005290BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860005597BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860010393BiopsybellBIOPSYBELL SRLKNW2023-09-05
08033860000080BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000103BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000127BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000165BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860000523BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860001063BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860003142BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860004255BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860004453BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860009311BiopsybellBIOPSYBELL SRLKNW2023-09-04
08033860001681BIOPSYBELL SRLBIOPSYBELL SRLKNW2023-08-31
08033860002909BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860002961BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860003203BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860003401BiopsybellBIOPSYBELL SRLKNW2023-08-31
08033860003777BiopsybellBIOPSYBELL SRLKNW2023-08-31