HS-Handpiece,straight,70mm,80k 1601104-001

GUDID 17630055506372

Bien-Air Surgery SA

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Primary Device ID17630055506372
NIH Device Record Key6988a448-62e2-4ffb-9e47-38e69abdb3f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS-Handpiece,straight,70mm,80k
Version Model Number362645
Catalog Number1601104-001
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 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
GS107630055506375 [Primary]
GS117630055506372 [Package]
Contains: 07630055506375
Package: [1 Units]
In Commercial Distribution

FDA Product Code

HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

Moist Heat or Steam Sterilization


[17630055506372]

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

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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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