HS Stand. Burr, Ø2.3x70, 50k 1100543-001

GUDID 17630055506846

Bien-Air Surgery SA

Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable Metal/carbide ENT bur, reusable
Primary Device ID17630055506846
NIH Device Record Keye776c06a-7d3c-44c7-8f38-a2d34250b95a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS Stand. Burr, Ø2.3x70, 50k
Version Model Number340123
Catalog Number1100543-001
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
GS107630055506849 [Primary]
GS117630055506846 [Package]
Contains: 07630055506849
Package: [1 Units]
In Commercial Distribution

FDA Product Code

EQJBur, Ear, Nose And Throat

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

Moist Heat or Steam Sterilization


[17630055506846]

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

Devices Manufactured by Bien-Air Surgery SA

27630055514626 - Bur PM2-70 80K diam C Ø2.3 St2024-04-09
27630055514732 - Bur PM2-70 80K diam C Ø3.1 St2024-04-09
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

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