KOMET STEINMANN PIN SP002.152.020

GUDID 84053613160489

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID84053613160489
NIH Device Record Keyb7d5db4c-0385-4d18-8993-219e2d359823
Commercial Distribution StatusIn Commercial Distribution
Brand NameKOMET STEINMANN PIN
Version Model NumberSP002.152.020.K4
Catalog NumberSP002.152.020
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
GS114053613160480 [Primary]
GS184053613160489 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


[84053613160489]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-28
Device Publish Date2020-12-18

On-Brand Devices [KOMET STEINMANN PIN]

E226045832K41SP002.228.016
E226045817K41SP002.101.016.K4
E226046068TW0804-07-338
E226046205K40SP004.228.032.K4
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.