Bur Cranial Spiral 25mm St 1101239-001

GUDID 17630055513820

Bien-Air Surgery SA

Cranial bur, single-use
Primary Device ID17630055513820
NIH Device Record Key2033e462-6b73-4111-9a95-733ba52bf03b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur Cranial Spiral 25mm St
Version Model Number1101239
Catalog Number1101239-001
Company DUNS481597719
Company NameBien-Air Surgery SA
Device Count1
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117630055513820 [Primary]

FDA Product Code

HBCMotor, Drill, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-12
Device Publish Date2024-12-04

On-Brand Devices [Bur Cranial Spiral 25mm St]

176300555037081100413
176300555138201101239

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