Cranio Guard 15mm rotating 1600879-001

GUDID J00716008790

Bien-Air Surgery SA

Trephining power tool attachment
Primary Device IDJ00716008790
NIH Device Record Key8bc096cd-e5eb-46ba-bd3e-fd6460ca5ac0
Commercial Distribution Discontinuation2023-02-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCranio Guard 15mm rotating
Version Model Number1600879
Catalog Number1600879-001
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 Datefalse
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
HIBCCJ00716008790 [Direct Marking]
HIBCCJ00716008790011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBCMotor, Drill, Electric

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


[J00716008790]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-02-10
Device Publish Date2019-01-07

On-Brand Devices [Cranio Guard 15mm rotating]

J007160087901600879
176300555058011600879

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