FDA.report

Arthrex®

Primary DI
00888867419803
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-7268GBL-01
Catalog number
AR-7268GBL-01
Device description
FiberTape Cerclage GBL Implants
Published
2023-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HTNWASHER, BOLT NUT

Product Code Classifications

CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867419803PrimaryGS10

GMDN Terms

TermDefinition
Internal orthopaedic fixation system, cerclage wire/cable, sterileA sterile assembly of implantable devices designed for general orthopaedic repairs including procedures for long bone fractures, hips, spine, bone grafting and reinforcement of bone. It may also be used for supplementary fixation and reduction with bone plate/screw systems. It typically consists of cerclage wires or cables and crimps and/or clamps made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy). It may also include instruments for the attachment of the implants such as crimping tool, cerclage wire/cable cutting tool, a tensioning tool, and a passer.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags

DUNS number
131747628
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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