PM PERFO 1600832-001

GUDID J00716008320

Bien-Air Surgery SA

Manual cranial rotary handpiece, reusable
Primary Device IDJ00716008320
NIH Device Record Key3ed3bd1f-bf05-4c3e-8832-cafd22f66b83
Commercial Distribution Discontinuation2023-02-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePM PERFO
Version Model Number1600832
Catalog Number1600832-001
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
HIBCCJ00716008320 [Direct Marking]
HIBCCJ00716008320011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBCMotor, Drill, Electric

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

Moist Heat or Steam Sterilization


[J00716008320]

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 [PM PERFO]

J007160083201600832
176300555057711600832

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