KOMET STEINMANN PIN SP002.101.016

GUDID E226045817K41

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device IDE226045817K41
NIH Device Record Keyca050317-435e-4356-ab22-306c1c9ce04f
Commercial Distribution StatusIn Commercial Distribution
Brand NameKOMET STEINMANN PIN
Version Model NumberSP002.101.016.K4
Catalog NumberSP002.101.016
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
GS114053613156711 [Primary]
GS184053613156710 [Unit of Use]
HIBCCE226045817K41 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


[E226045817K41]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-21
Device Publish Date2018-12-21

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E226045817K41SP002.101.016.K4
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84053613161486SP004.228.040.K4
84053613160656SP002.228.024.K4
84053613160632SP002.228.020.K4
84053613160489SP002.152.020.K4
84053613159964SP001.228.024.k4
84053613159940SP001.228.020.K4
84053613159926SP001.152.048.K4
84053613159865SP001.152.032.K4
84053613159247SP003.228.024.K4
84053613156918SP002.152.016.K4
84053613155911SP001.152.016.K4
84053613161240SP001.152.020.K4
84053613159827SP001.152.024.K4
84053613156413SP004.152.016.K4
84053613160670SP002.228.028.K4
84053613155812SP001.127.016.K4
24053613285586SP001.300.032.M1

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