FDA.report

Arthrex®

Primary DI
00888867039773
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-6520-4
Catalog number
AR-6520-4
Device description
DILATOR, 4 MM REPLACEMENT FOR AR-6520S
Published
2018-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NBHAccessories, arthroscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867039773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867039773008888670397738888670397730888867039773

GMDN Terms

TermDefinition
Orthopaedic trocar blade, reusableA rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13
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00888867310209Arthrex®AR-4158TAR-4158T2019-11-15
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00888867561700Arthrex®AR-2600FSF-3AR-2600FSF-32026-03-17
00888867463363Arthrex®AR-8974-02AR-8974-022026-03-16
00888867519459Arthrex®AR-8974FCAR-8974FC2026-03-16
00888867519473Arthrex®AR-8974FCLAR-8974FCL2026-03-16
00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
00888867519510Arthrex®AR-8974TLAR-8974TL2026-03-16
00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
00888867529052Arthrex®AR-8827H-14AR-8827H-142026-03-16

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