FDA.report

Arthrex®

Primary DI
00888867427068
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-S7700-075-160
Catalog number
AR-S7700-075-160
Device description
Trephine Protection Tube, 7.5 x 160mm
Published
2023-06-05
Public version status
New
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
HWKTREPHINE

Product Code Classifications

CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867427068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867427068008888674270688888674270680888867427068

GMDN Terms

TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. 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
true
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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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
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