K-Wire Threaded Ø1,4x89mm ED-10989

GUDID 84053613287155

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID84053613287155
NIH Device Record Keyedc67b2e-9972-4f44-a583-4e27becb888c
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-Wire Threaded Ø1,4x89mm
Version Model NumberED-10989
Catalog NumberED-10989
Company DUNS317409001
Company NameGebr. Brasseler GmbH & Co. KG
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS114053613287156 [Primary]
GS184053613287155 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-25
Device Publish Date2023-12-15

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