FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867461765
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-01-04-004
Catalog number
AR-01-04-004
Device description
Aseptic Transfer Kit
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867461765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867461765008888674617658888674617650888867461765

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867461741Arthrex®AR-01-04-002AR-01-04-0022026-11-05
00888867461758Arthrex®AR-01-04-003AR-01-04-0032026-11-05
00888867473553Arthrex®AR-1288QAI-100AR-1288QAI-1002025-03-18
00888867473560Arthrex®AR-1288QAI-110AR-1288QAI-1102025-03-18
00888867473577Arthrex®AR-1288QAI-80AR-1288QAI-802025-03-18
00888867473584Arthrex®AR-1288QAI-90AR-1288QAI-902025-03-18
00888867473638Arthrex®AR-1288QTT-100AR-1288QTT-1002025-03-18
00888867473645Arthrex®AR-1288QTT-110AR-1288QTT-1102025-03-18
00888867473652Arthrex®AR-1288QTT-80AR-1288QTT-802025-03-18
00888867473669Arthrex®AR-1288QTT-90AR-1288QTT-902025-03-18
00888867034372Arthrex®AR-502-1LAR-502-1L2017-02-15
00888867034389Arthrex®AR-502-1RAR-502-1R2017-02-15
00888867034396Arthrex®AR-502-2LAR-502-2L2017-02-15
00888867034402Arthrex®AR-502-2RAR-502-2R2017-02-15
00888867034570Arthrex®AR-502-3LAR-502-3L2017-02-15
00888867034587Arthrex®AR-502-3RAR-502-3R2017-02-15
00888867034662Arthrex®AR-502-4LAR-502-4L2017-12-06
00888867034679Arthrex®AR-502-4RAR-502-4R2017-02-15
00888867035546Arthrex®AR-504-PSA8AR-504-PSA82017-02-15
00888867035560Arthrex®AR-504-PSC9AR-504-PSC92017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867461741Arthrex®ARTHREX, INC.HWE2026-11-05
00888867461758Arthrex®ARTHREX, INC.HWE2026-11-05
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04250337122333Olive Cutter, Olive Tip, with side protectionJoimax GmbHHWE2026-11-03
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774202MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774226MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774240MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774257MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000774301MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000777692MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
00763000777739MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-31
09421038413753Enztec Modular Planer Handle - ZimmerENZTEC LIMITEDHWE2026-10-30
09421038413760Enztec Modular Planer Handle - Large AOENZTEC LIMITEDHWE2026-10-30
09421038413777Enztec Modular Planer Handle - HudsonENZTEC LIMITEDHWE2026-10-30
09421038413784Enztec Modular Planer 38mm – 7.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413791Enztec Modular Planer 38mm – 8.00mm IDENZTEC LIMITEDHWE2026-10-30
09421038413807Enztec Modular Planer 45mm – 7.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413814Enztec Modular Planer 45mm – 8.00mm IDENZTEC LIMITEDHWE2026-10-30
09421038413821Enztec Modular Planer 45mm – 8.10mm IDENZTEC LIMITEDHWE2026-10-30
09421038413838Enztec Modular Planer 38mm – 8.10mm IDENZTEC LIMITEDHWE2026-10-30
04250337121794"Shrill® Deflector Shaft 2, WL= 320mm, reusable"Joimax GmbHHWE2026-10-29
04250337122388Deflector Bone Resector, Bullet-Tip, disposableJoimax GmbHHWE2026-10-29