FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867550407
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-S4065K-4-S
Catalog number
AR-S4065K-4-S
Device description
Safe Access Kit, Spine 4"
Published
2026-10-23
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
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
10888867550404PackageGS110In Commercial Distribution
00888867550407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886755040410888867550404
00888867550407008888675504078888675504070888867550407

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

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
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
00888867550391Arthrex®AR-S4064K-6N-SAR-S4064K-6N-S2026-10-23
00888867550414Arthrex®AR-S4065K-6-SAR-S4065K-6-S2026-10-23
00888867550421Arthrex®AR-S4065K-8-SAR-S4065K-8-S2026-10-23
00888867576032Arthrex®AR-3636-REMPAR-3636-REMP2026-10-20
00888867576056Arthrex®AR-3641SP-REMPAR-3641SP-REMP2026-10-20
00888867576070Arthrex®AR-6573-1AR-6573-12026-10-20
00888867576087Arthrex®AR-6573-2AR-6573-22026-10-20
00888867568280Arthrex®AR-3210-0050-SJAR-3210-0050-SJ2026-10-16
00888867568297Arthrex®AR-3210-0051-SJAR-3210-0051-SJ2026-10-16
00888867568303Arthrex®AR-3210-0059-PKAR-3210-0059-PK2026-10-16
00888867568310Arthrex®AR-3210-0063-PKAR-3210-0063-PK2026-10-16
00888867568457Arthrex®AR-8650DS-NAR-8650DS-N2026-10-16
00888867427143Arthrex®AR-S6524-025-230CAR-S6524-025-230C2023-06-05
00888867389533Arthrex®AR-9928BCK-MISAR-9928BCK-MIS2023-05-22
00888867276086Arthrex®AR-9437-16AR-9437-162022-07-15
00888867060401Arthrex®AR-9439-16AR-9439-162018-06-02
00888867060418Arthrex®AR-9439-18AR-9439-182018-06-02
00888867060425Arthrex®AR-9441-16AR-9441-162018-06-14
00888867060432Arthrex®AR-9441-18AR-9441-182018-06-02
00888867060449Arthrex®AR-9443-16AR-9443-162018-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23
M739985203530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23