HS Craniotome Burr, short, 80k 1100605-001

GUDID 27630055507468

Bien-Air Surgery SA

Cranial bur, single-use
Primary Device ID27630055507468
NIH Device Record Key572f7ed8-39ca-4b4c-bea9-4bafdfeb6b79
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS Craniotome Burr, short, 80k
Version Model Number362640 S
Catalog Number1100605-001
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
GS117630055507461 [Primary]
GS127630055507468 [Package]
Contains: 17630055507461
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-02
Device Publish Date2023-02-22

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17630055513783 - Bur PM2 80K Steel TD Ø1.1x5 St2024-12-12
17630055513790 - Bur PM2 80K Steel TD Ø1.1x4 St2024-12-12
17630055513813 - Bur Cranial Straight 25 mm St2024-12-12
17630055513820 - Bur Cranial Spiral 25mm St2024-12-12
17630055513837 - Bur Cranial Spiral 10mm St2024-12-12
17630055513844 - Bur Cranial Straight 10mm St2024-12-12

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