FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867395084
Brand
Arthrex®
Company
ARTHREX, INC.
Model
ABS-4402
Catalog number
ABS-4402
Device description
SPEEDFLEX 20 x 25 x 1mm Presutured Graft
Published
2025-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSuture, nonabsorbable, synthetic, polyethylene
OWYMesh, surgical, collagen, orthopaedics, reinforcement of tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867395084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867395084008888673950848888673950840888867395084

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
HCT/P
true
Lot or batch
true
Serial number
true
Expiration date on label
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
00888867461765Arthrex®AR-01-04-004AR-01-04-0042026-11-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653900497PremicronB BRAUN SURGICAL SAGAT2015-11-11
04038653914050PremicronB BRAUN SURGICAL SAGAT2015-11-05
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04038653991822PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003853PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003914PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439003921PremicronB BRAUN SURGICAL SAGAT2015-11-05
04045439020690PremicronB BRAUN SURGICAL SAGAT2015-11-05
04038653991785PremicronB BRAUN SURGICAL SAGAT2015-11-05
10884521072657V-LocCovidien LPGAT2015-09-02
04038653983919PremicronB BRAUN SURGICAL SAGAT2015-08-27
04038653983544PremicronB BRAUN SURGICAL SAGAT2015-08-27
04038653750337PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653750450PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653871230PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900480PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900695PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900701PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900725PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653911035PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653922246PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439000944PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439001002PremicronB BRAUN SURGICAL SAGAT2015-08-26
04045439059072PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900503PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900510PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900732PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653988402PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653951048PremicronB BRAUN SURGICAL SAGAT2015-08-26
04038653900541PremicronB BRAUN SURGICAL SAGAT2015-08-26