FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867100671
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-3240-3530
Catalog number
AR-3240-3530
Device description
Fused UNI LHT CBL,3.5mmX 274cm,Gr
Published
2022-07-29
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
FSTLIGHT, SURGICAL, FIBEROPTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901035000FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLECuda Products Co.1990-04-23FST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867100671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867100671008888671006718888671006710888867100671

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. 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
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
00888867386440Arthrex®AR-18827-06AR-18827-062023-01-28
00888867386457Arthrex®AR-18827-07AR-18827-072023-01-28
00888867343092Arthrex®AR-8924VNR-07SAR-8924VNR-07S2023-05-25
00888867386266Arthrex®AR-18800C-03AR-18800C-032023-01-28
00888867386303Arthrex®AR-18800C-27AR-18800C-272023-01-28
00888867387218Arthrex®AR-18800CAR-18800C2023-01-28
00888867472433Arthrex®AR-18827-54AR-18827-542025-04-09
00888867472457Arthrex®AR-18827-58AR-18827-582025-04-09
00888867498242Arthrex®AR-8935-74AR-8935-742025-04-09
00888867498259Arthrex®AR-8935-76AR-8935-762025-04-09
00888867498266Arthrex®AR-8935-78AR-8935-782025-04-09
00888867026940Arthrex®AR-2324SLMAR-2324SLM2017-02-15
00888867098169Arthrex®AR-2324SLM-1AR-2324SLM-12018-08-31
00888867614956Arthrex®AR-S8457EXCAR-S8457EXC2026-05-25
00888867531949Arthrex®AR-8827H-22SAR-8827H-22S2026-03-16
00888867531970Arthrex®AR-8827H-28SAR-8827H-28S2026-03-16
00888867531987Arthrex®AR-8827H-30SAR-8827H-30S2026-03-16
00888867532014Arthrex®AR-8827H-36SAR-8827H-36S2026-03-16
00888867134874Arthrex®AR-9104-04AR-9104-042017-02-15
00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13

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