FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867216792
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-3352-5530L
Catalog number
AR-3352-5530L
Device description
4K LAPAROSCOPE,30°,5.5x424MM,Hi-Mag,XL
Published
2017-12-06
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
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941541000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941541000HSV LAPAROSCOPY SETHenke Sass Wolf of America, Inc.1994-05-16GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867216792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867216792008888672167928888672167920888867216792

GMDN Terms#

Term, Definition table
TermDefinition
Rigid arthroscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. 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
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867050037Arthrex®AR-8933L-14SAR-8933L-14S2017-08-31
00888867050051Arthrex®AR-8933L-16SAR-8933L-16S2017-08-31
00888867050075Arthrex®AR-8933L-18SAR-8933L-18S2017-08-31
00888867051324Arthrex®AR-8940-16SAR-8940-16S2017-03-03
00888867051348Arthrex®AR-8940-18SAR-8940-18S2017-03-03
00888867051386Arthrex®AR-8940-22SAR-8940-22S2017-03-03
00888867051447Arthrex®AR-8940-28SAR-8940-28S2017-03-03
00888867051485Arthrex®AR-8940-32SAR-8940-32S2017-03-03
00888867051560Arthrex®AR-8940-40SAR-8940-40S2017-03-03
00888867051584Arthrex®AR-8940-42SAR-8940-42S2017-03-03
00888867053304Arthrex®AR-8945-22FTSAR-8945-22FTS2017-08-31
00888867053496Arthrex®AR-8945-30PTSAR-8945-30PTS2017-08-31
00888867053533Arthrex®AR-8945-32PTSAR-8945-32PTS2017-08-31
00888867053649Arthrex®AR-8945-36PTSAR-8945-36PTS2017-08-31
00888867053687Arthrex®AR-8945-38PTSAR-8945-38PTS2017-08-31
00888867053724Arthrex®AR-8945-40PTSAR-8945-40PTS2017-08-31
00888867053755Arthrex®AR-8945-45FTSAR-8945-45FTS2017-08-31
00888867053816Arthrex®AR-8945-50PTSAR-8945-50PTS2017-08-31
00888867053854Arthrex®AR-8945-55PTSAR-8945-55PTS2017-08-31
00888867053892Arthrex®AR-8945-60PTSAR-8945-60PTS2017-08-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
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08806182210396LaportSejong Medical Co., LtdGCJ2018-04-05
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