RA XL Ø2.35x34 Zekrya 1100870-001

GUDID 17630055517156

Bien-Air Surgery SA

Steel dental bur, single-use
Primary Device ID17630055517156
NIH Device Record Keybc4b86b9-42cf-4f97-8ffc-785e65d878cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRA XL Ø2.35x34 Zekrya
Version Model Number1100870
Catalog Number1100870-001
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS117630055517156 [Primary]
GS117630055517637 [Package]
Package: [3 Units]
In Commercial Distribution

FDA Product Code

GFFBur, Surgical, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-09
Device Publish Date2024-11-29

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