NEOFUSE

GUDID 03760225717127

IN2BONES

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable
Primary Device ID03760225717127
NIH Device Record Keycd0e4a75-32c7-4f20-affb-224bf017a093
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEOFUSE
Version Model NumberG01 01561
Company DUNS263616749
Company NameIN2BONES
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 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
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]
GS103760225717127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver
HXXScrewdriver

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


[03760225717127]

Moist Heat or Steam Sterilization


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 [NEOFUSE]

03760225717097P02 00151
03760225717066P02 00191
03760225717028P02 00141
03760225717059P02 00131
03760225717035P02 00201
03760225717141G01 01571
03760225717127G01 01561
03760225715857G01 10321

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