PMRM 1122 95mm 1600340-001

GUDID J00716003400

Bien-Air Surgery SA

Drilling power tool attachment, basic
Primary Device IDJ00716003400
NIH Device Record Keyf178bbb4-57c1-45dc-a1ae-bcd8f8ec0d75
Commercial Distribution StatusIn Commercial Distribution
Brand NamePMRM 1122 95mm
Version Model Number1600340
Catalog Number1600340-001
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
HIBCCJ00716003400 [Direct Marking]
HIBCCJ00716003400011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

Moist Heat or Steam Sterilization


[J00716003400]

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 [PMRM 1122 95mm]

J007160034001600340
176300555051771600340

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