FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867431379
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-3375-4202A
Catalog number
AR-3375-4202A
Device description
TROCAR F/ IN/OUT PANO SCOPE SHEATH
Published
2024-01-09
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
NBHAccessories, arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867431379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867431379008888674313798888674313790888867431379

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic trocar blade, reusableA rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. 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
00888867550391Arthrex®AR-S4064K-6N-SAR-S4064K-6N-S2026-10-23
00888867550407Arthrex®AR-S4065K-4-SAR-S4065K-4-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867576070Arthrex®ARTHREX, INC.NBH2026-10-20
00888867576087Arthrex®ARTHREX, INC.NBH2026-10-20
00888867568280Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568297Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568303Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568310Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568457Arthrex®ARTHREX, INC.NBH2026-10-16
B382SD4830070Surgical DirectSurgical Direct, Inc.NBH2026-10-15
B382SD4840320Surgical DirectSurgical Direct, Inc.NBH2026-10-15
B382SD18146S90Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316490Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316690Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316890Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD4810320Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD482014PH0Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD482036PH0Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD4843590Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD488200810Surgical DirectSurgical Direct, Inc.NBH2026-10-13
00888867620964Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620971Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620988Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620995Arthrex®ARTHREX, INC.NBH2026-10-12
00190776434021MillenniumAvalign Technologies, Inc.NBH2026-10-09
00190776434106MillenniumAvalign Technologies, Inc.NBH2026-10-09
00190776433680MillenniumAvalign Technologies, Inc.NBH2026-10-07
00190776433123MillenniumAvalign Technologies, Inc.NBH2026-10-01
04055207071786NARichard Wolf GmbHNBH2026-10-01
04055207071830NARichard Wolf GmbHNBH2026-10-01
00190776431495MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776432119MillenniumAvalign Technologies, Inc.NBH2026-09-22