Bur PM2-150 80K Diam Ø1.8 St 1100330-001

GUDID 27630055503019

Bien-Air Surgery SA

Diamond ENT bur, single-use
Primary Device ID27630055503019
NIH Device Record Keyfeae52ee-a455-4bd4-8435-29330d3c67cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBur PM2-150 80K Diam Ø1.8 St
Version Model Number1100330
Catalog Number1100330-001
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
GS117630055503012 [Primary]
GS127630055503019 [Package]
Contains: 17630055503012
Package: Box [1 Units]
In Commercial Distribution
HIBCCJ00711003300011 [Previous]

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 Date2023-02-16
Device Publish Date2023-02-08

On-Brand Devices [Bur PM2-150 80K Diam Ø1.8 St]

276300555030191100330
176300555156881101208

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.