FDA.report

Arthrex®

Primary DI
00888867019652
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1588TDB-7
Catalog number
AR-1588TDB-7
Device description
ACL TIGHTROPE DB, 7MM
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HTYPIN, FIXATION, SMOOTH
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications

CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867019652PrimaryGS10
M150AR1588TDB71SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867019652008888670196528888670196520888867019652

GMDN Terms

TermDefinition
Orthopaedic bone washer, sterileA sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
131747628
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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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