IBS™

GUDID 03760225712559

IN2BONES

Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use, sterile
Primary Device ID03760225712559
NIH Device Record Keydafd5482-1224-4466-bf85-419dc8210402
Commercial Distribution StatusIn Commercial Distribution
Brand NameIBS™
Version Model NumberG01 01371
Company DUNS263616749
Company NameIN2BONES
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 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
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]
GS103760225712559 [Primary]

FDA Product Code

GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical
GFGBit, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

On-Brand Devices [IBS™]

03701337605513Snap-off screw titanium
03701337605506Snap-off screw titanium
03701337605490Snap-off screw titanium
03701337605483Snap-off screw titanium
03701337605476Snap-off screw titanium
03701337605469Snap-off screw titanium
03701337605452Snap-off screw titanium
03701337605339Snap-off screw titanium
03701337605322Snap-off screw titanium
03701337605315Snap-off screw titanium
03701337605308Snap-off screw titanium
03701337605292Snap-off screw titanium
03701337605285Snap-off screw titanium
03760225715321S20 ST021
03760225715284S20 ST013
03760225715277S20 ST011
03760225715246IBS™ Neutralization screw
03760225714935G01 01372
03760225714492G01 01362
03760225714485G01 01352
03760225713099G01 01181
03760225713037G01 01351
03760225712573G01 01381
03760225712559G01 01371
03760225712535G01 01361

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