Bur Cranial Straight 25 mm St 1100414-001

GUDID 27630055503712

Bien-Air Surgery SA

Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use
Primary Device ID27630055503712
NIH Device Record Key93ff0930-13bd-4a2f-9d0b-5ae56b009880
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur Cranial Straight 25 mm St
Version Model Number1100414
Catalog Number1100414-001
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
GS117630055503715 [Primary]
GS127630055503712 [Package]
Contains: 17630055503715
Package: Box [1 Units]
In Commercial Distribution
HIBCCJ00711004140011 [Previous]

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 Date2023-02-17
Device Publish Date2023-02-09

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