HS Stand. Burr, Ø1.8x70, 50k 1100542-001

GUDID 17630055506839

Bien-Air Surgery SA

Metal/carbide ENT bur, reusable
Primary Device ID17630055506839
NIH Device Record Key07451f87-a474-460d-bc2a-a92881f8310a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS Stand. Burr, Ø1.8x70, 50k
Version Model Number340118
Catalog Number1100542-001
Company DUNS481597719
Company NameBien-Air Surgery SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS107630055506832 [Primary]
GS117630055506839 [Package]
Contains: 07630055506832
Package: [1 Units]
In Commercial Distribution

FDA Product Code

EQJBur, Ear, Nose And Throat

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


[17630055506839]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-02
Device Publish Date2023-02-22

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17630055515756 - Bur PM2-70 80K diam Ø0.6 St2024-04-09
17630055515763 - Bur PM2-70 80K diam Ø0.8 St2024-04-09
27630055515777 - Bur PM2-70 80K diam Ø1.0 St2024-04-09
27630055515784 - Bur PM2-70 80K diam Ø1.4 St2024-04-09
27630055515791 - Bur PM2-70 80K diam Ø1.8 St2024-04-09
27630055515807 - Bur PM2-70 80K diam Ø2.3 St2024-04-09

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