FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867464438
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-S3420-075-15540
Catalog number
AR-S3420-075-15540
Device description
Cannula w/ Oblq Window: 7.5 x 155mm, 40°
Published
2025-06-13
Public version status
New
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
00888867464438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867464438008888674644388888674644380888867464438

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic access cannula, reusableA single-lumen, surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. 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
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
00888867304598Arthrex®AR-7285AR-72852026-07-08
00888867304604Arthrex®AR-7286AR-72862026-07-08
00888867304789Arthrex®AR-7285-1AR-7285-12026-07-08
00888867304796Arthrex®AR-7286-1AR-7286-12026-07-08
00888867023987Arthrex®AR-1934BFT-2AR-1934BFT-22019-03-09
00888867097216Arthrex®AR-1938PHSAR-1938PHS2017-05-11
00888867157767Arthrex®AR-1588TN-2AR-1588TN-22017-08-15
00888867178649Arthrex®AR-8827L-32SAR-8827L-32S2017-04-07
00888867178694Arthrex®AR-8827L-42SAR-8827L-42S2017-04-07
00888867178731Arthrex®AR-8827L-50SAR-8827L-50S2017-04-07
00888867178748Arthrex®AR-8827L-52SAR-8827L-52S2017-04-07
00888867178755Arthrex®AR-8827L-54SAR-8827L-54S2017-05-11
00888867178762Arthrex®AR-8827L-56SAR-8827L-56S2017-05-11
00888867178779Arthrex®AR-8827L-58SAR-8827L-58S2017-05-11
00888867179455Arthrex®AR-8835-65SAR-8835-65S2017-04-07
00888867179462Arthrex®AR-8835-70SAR-8835-70S2017-04-07
00888867179479Arthrex®AR-8835-75SAR-8835-75S2017-04-07
00888867179486Arthrex®AR-8835-80SAR-8835-80S2017-04-07
00888867196537Arthrex®AR-8943C-07SAR-8943C-07S2017-05-11
00888867196582Arthrex®AR-8943C-12SAR-8943C-12S2017-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500050Surgical DirectSurgical Direct, Inc.LXH2026-07-09