HS Craniotome Burr, long 80k 1100607-001

GUDID 27630055507482

Bien-Air Surgery SA

Cranial bur, single-use
Primary Device ID27630055507482
NIH Device Record Key04a80a81-b337-4841-81f5-d32069cb8078
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS Craniotome Burr, long 80k
Version Model Number362640 L
Catalog Number1100607-001
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
GS117630055507485 [Primary]
GS127630055507482 [Package]
Contains: 17630055507485
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2023-03-02
Device Publish Date2023-02-22

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17630055513073 - Bur PM2-70 80K steel Ø5.0x80 sterile2026-02-19
17630055513394 - Bur PM2-95 80K steel Ø2 sterile2026-02-19
17630055513417 - Bur PM2-95 80K steel Ø3 sterile2026-02-19
17630055513486 - Bur PM2-125 80K steel Ø1 sterile2026-02-19
17630055513509 - Bur PM2-125 80K steel Ø2 sterile2026-02-19
17630055513523 - Bur PM2-125 80K steel Ø3 sterile2026-02-19

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