FDA.report

Arthrex®

Primary DI
10888867010366
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1324HF
Catalog number
AR-1324HF
Device description
SUTR ANCH,FASTAK II
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
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888867010366PrimaryGS10
M150AR1324HF1SecondaryHIBCC0
00888867010369Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886701036610888867010366
00888867010369008888670103698888670103690888867010369

GMDN Terms

TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
131747628
Device count
5
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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00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
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00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
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00888867529083Arthrex®AR-8827H-20AR-8827H-202026-03-16
00888867529090Arthrex®AR-8827H-22AR-8827H-222026-03-16
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00888867529113Arthrex®AR-8827H-26AR-8827H-262026-03-16
00888867529120Arthrex®AR-8827H-28AR-8827H-282026-03-16
00888867529137Arthrex®AR-8827H-30AR-8827H-302026-03-16
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