Cranio Guard 10mm fix 1600912-001

GUDID 17630055505863

Bien-Air Surgery SA

Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment Trephining power tool attachment
Primary Device ID17630055505863
NIH Device Record Key58b44b75-431f-4f79-9ed9-bd6d128c36c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCranio Guard 10mm fix
Version Model Number1600912
Catalog Number1600912-001
Company DUNS481597719
Company NameBien-Air Surgery SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS107630055505866 [Primary]
GS117630055505863 [Package]
Contains: 07630055505866
Package: [1 Units]
In Commercial Distribution
HIBCCJ00716009120011 [Previous]

FDA Product Code

HBCMotor, Drill, Electric

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


[17630055505863]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-20
Device Publish Date2023-02-10

On-Brand Devices [Cranio Guard 10mm fix]

J007160091201600912
176300555058631600912

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