R3FLEX 2.8mm Cannulated Drill w/ 1.6mm Steinmann Pin P82-912-0000-SK

GUDID 14053613293065

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bur, single-use
Primary Device ID14053613293065
NIH Device Record Keybbc39ed2-3482-4ebd-aea7-35f5e984e8bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameR3FLEX 2.8mm Cannulated Drill w/ 1.6mm Steinmann Pin
Version Model NumberP82-912-0000-SK
Catalog NumberP82-912-0000-SK
Company DUNS317409001
Company NameGebr. Brasseler GmbH & Co. KG
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 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
GS114053613293065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2025-04-15
Device Publish Date2025-04-07

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