FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867387331
Brand
Arthrex®
Company
ARTHREX, INC.
Model
ABS-10062K-TH13OTA
Catalog number
ABS-10062K-TH13OTA
Device description
W/ ACD-A 13G OPEN TIP BMA ANGEL KIT
Published
2022-01-13
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
ORGPlatelet and plasma separator for bone graft handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867387331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867387331008888673873318888673873310888867387331

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
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
08685139210012ExoCubeEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210029Exocube SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210067ExoCube-20PackEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08809410200053Dr.PRPRmedica Co.,LtdORG2026-02-02
G668FG0010ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
G668FG0011ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFIDIA FARMACEUTICI SPAORG2025-10-31
14719875912242Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912259Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
10850075308115Cervos Platelet Separator Triple Pack B2RANFAC CORP.ORG2025-07-23
04719875912122Virtue CPKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912139Virtue CPKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912146Virtue CPKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912153Virtue CPKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912160Virtue CPKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912177Virtue CPKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912184Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912191Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912207Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912214Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912221Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
04719875912238Virtue ACKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15
10850075308023Cervos Platelet Separator Single 5 PackRANFAC CORP.ORG2025-05-14
08435389826903ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-04-14
08435389828037ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-04-14
08435389828044ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-04-14
08435389828051ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-04-14
08435389828068ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-04-14
08435389828075ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-04-14
08435389828082ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-04-14