KOMET K-Wire KW003.228.009

GUDID 84053613157434

Gebr. Brasseler GmbH & Co. KG

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Primary Device ID84053613157434
NIH Device Record Key4ed49962-61aa-4140-9d97-10e666e877a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameKOMET K-Wire
Version Model NumberKW003.228.009.K4
Catalog NumberKW003.228.009
Company DUNS317409001
Company NameGebr. Brasseler GmbH & Co. KG
Device Count10
DM Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS114053613157435 [Primary]
GS184053613157434 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

[84053613157434]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-07
Device Publish Date2021-06-29

On-Brand Devices [KOMET K-Wire]

E226045831K41KW002.228.014
E226045816K41KW002.101.014.K4
E226045815K41KW002.101.011
84053613156970KW002.228.011.K4
84053613156895KW002.152.014.K4
84053613156871KW002.152.011.K4
84053613156857KW002.152.009.K4
84053613156833KW002.152.007.K4
84053613156659KW002.101.009.K4
84053613155973KW001.228.011.K4
84053613155898KW001.152.014.K4
84053613155874KW001.152.011.K4
84053613155850KW001.152.009.K4
84053613155836KW001.152.007.K4
84053613157434KW003.228.009.K4
84053613156390KW004.152.014.K4
84053613156376KW004.152.011.K4
84053613156352KW004.152.009.K4
84053613156338KW004.152.007.K4
84053613157151KW003.101.011.K4
84053613156956KW002.228.009.K4
84053613156475KW004.228.011.K4
84053613156451KW004.228.009.K4
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