Steinmann Pins, K-Wire, smooth SP003.101.016

GUDID 84053613157199

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID84053613157199
NIH Device Record Key5c4b222d-571b-47f7-8daf-a42beae1188a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteinmann Pins, K-Wire, smooth
Version Model NumberSP003.101.016.K4
Catalog NumberSP003.101.016
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 Datetrue
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
GS114053613157190 [Primary]
GS184053613157199 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

[84053613157199]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-09
Device Publish Date2023-02-01

On-Brand Devices [Steinmann Pins, K-Wire, smooth]

84053613164753KW001.070.007.K4
84053613161400SP004.228.024.K4
84053613161387SP004.228.020.K4
84053613161264SP004.152.024.K4
84053613161042SP004.101.024.K4
84053613161028SP004.101.020.K4
84053613160922SP004.070.020.K4
84053613160908SP004.127.024.K4
84053613160885SP004.127.020.K4
84053613160823SP004.070.024.K4
84053613160731SP002.228.040.K4
84053613160717SP002.228.036.K4
84053613160694SP002.228.032.K4
84053613160502SP002.152.024.K4
84053613160366SP002.127.024.K4
84053613160342SP002.127.020.K4
84053613160229SP002.101.024.K4
84053613160205SP002.101.020.K4
84053613160083SP002.070.024.K4
84053613160069SP002.070.020.K4
84053613160045SP001.228.048.K4
84053613160021SP001.228.040.K4
84053613160007SP001.228.036.K4
84053613159988SP001.228.032.K4
84053613159780SP001.127.024.K4
84053613159766SP001.127.020.K4
84053613159643SP001.101.024.K4
84053613159629SP001.101.020.K4
84053613159506SP001.070.024.K4
84053613159483SP001.070.020.K4
84053613159360SP001.228.028.K4
84053613159223SP003.228.020.K4
84053613159100SP003.152.024.K4
84053613159087SP003.152.020.K4
84053613158967SP003.127.020.K4
84053613158868SP003.101.024.K4
84053613158844SP003.101.020.K4
84053613158820SP003.070.020.K4
84053613158707SP003.070.024.K4
84053613158684SP002.228.048.K4
84053613157519KW004.101.007.K4
84053613157496SP003.228.016.K4
84053613157472KW003.228.014.K4
84053613157458KW003.228.011.K4
84053613157410KW003.228.007.K4
84053613157397SP003.152.016.K4
84053613157373KW003.152.014.K4
84053613157359KW003.152.011.K4
84053613157335KW003.152.009.K4
84053613157311KW003.152.007.K4
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