HEALIX TRANSTEND 222341

GUDID 10886705023868

DEPUY MITEK, LLC

Tendon/ligament bone anchor, bioabsorbable
Primary Device ID10886705023868
NIH Device Record Key73009b3b-78a0-4935-922e-b1e9c5b68e39
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEALIX TRANSTEND
Version Model Number222341
Catalog Number222341
Company DUNS190572854
Company NameDEPUY MITEK, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705023868 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRStaple, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


[10886705023868]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-12
Device Publish Date2025-03-04

On-Brand Devices [HEALIX TRANSTEND]

10886705020331HEALIX TRANSTEND Drill Bit 2.2mm
10886705008186HEALIX TRANSTEND 3.4mm Awl/Tap
10886705023868222341

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