FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867106901
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-5068S
Catalog number
AR-5068S
Device description
SUTRLASSO TM SD SUTR PASS SYS SET
Published
2018-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867106901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867106901008888671069018888671069010888867106901

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

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
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867460973Arthrex®AR-9001A-7140CSAR-9001A-7140CS2026-06-11
00888867179493Arthrex®AR-8835L-08SAR-8835L-08S2017-04-07
00888867186293Arthrex®AR-8835-08SAR-8835-08S2017-03-03
00888867202733Arthrex®AR-8948W-2045AR-8948W-20452017-02-25
00888867237612Arthrex®AR-8827L-08SAR-8827L-08S2017-05-11
00888867238602Arthrex®AR-1927PSF-475AR-1927PSF-4752017-05-05
00888867483927Arthrex®AR-4020C-06DAR-4020C-06D2025-11-06
00888867525924Arthrex®AR-7269RAR-7269R2025-10-20
00888867456174Arthrex®AR-3610NDF-1AR-3610NDF-12025-11-14
00888867456181Arthrex®AR-3610NDF-2AR-3610NDF-22025-11-14
00888867456198Arthrex®AR-3610NDF-3AR-3610NDF-32025-11-14
00888867456204Arthrex®AR-3610NDF-4AR-3610NDF-42025-11-14
00888867525931Arthrex®AR-7269R-1AR-7269R-12025-10-20
00888867465220Arthrex®AR-1588SBR-RTAR-1588SBR-RT2025-06-23
00888867465237Arthrex®AR-1588SBR-RT-IBAR-1588SBR-RT-IB2025-06-23
00888867465244Arthrex®AR-1588SBR-RT-IBRAR-1588SBR-RT-IBR2025-06-23
00888867501324Arthrex®AR-1588SBR-RTT-IBAR-1588SBR-RTT-IB2025-06-23
00888867501331Arthrex®AR-1588SBR-RTT-IBRAR-1588SBR-RTT-IBR2025-06-23
00888867458048Arthrex®AR-S1000-C4AR-S1000-C42024-01-23
00888867426023Arthrex®AR-3711AR-37112023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150002139N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00199150002146N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754730N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00822409082124N/AOrtho Development CorporationLXH2026-07-16
00822409082131N/AOrtho Development CorporationLXH2026-07-16
00822409082148N/AOrtho Development CorporationLXH2026-07-16
00822409082155N/AOrtho Development CorporationLXH2026-07-16
00822409082162N/AOrtho Development CorporationLXH2026-07-16
00822409082179N/AOrtho Development CorporationLXH2026-07-16
00822409082186N/AOrtho Development CorporationLXH2026-07-16
00822409082193N/AOrtho Development CorporationLXH2026-07-16
00822409082209N/AOrtho Development CorporationLXH2026-07-16
00822409082216N/AOrtho Development CorporationLXH2026-07-16
00822409082223N/AOrtho Development CorporationLXH2026-07-16
00822409082230N/AOrtho Development CorporationLXH2026-07-16
00822409082247N/AOrtho Development CorporationLXH2026-07-16
00822409082254N/AOrtho Development CorporationLXH2026-07-16
00822409082261N/AOrtho Development CorporationLXH2026-07-16
00822409082278N/AOrtho Development CorporationLXH2026-07-16
00822409082285N/AOrtho Development CorporationLXH2026-07-16
00822409082292N/AOrtho Development CorporationLXH2026-07-16
00822409082308N/AOrtho Development CorporationLXH2026-07-16
00822409082315N/AOrtho Development CorporationLXH2026-07-16
00822409082322N/AOrtho Development CorporationLXH2026-07-16
00822409082339N/AOrtho Development CorporationLXH2026-07-16
00822409082346N/AOrtho Development CorporationLXH2026-07-16
00840606188135Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188142Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188159Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16