FuzeFix Twist Off TN-FX-8030

GUDID 00819034023196

TN-FX-8030 Depth Guage

FUSION ORTHOPEDICS, LLC

Surgical depth gauge, single-use
Primary Device ID00819034023196
NIH Device Record Key5bff9e00-c9d4-4a92-8dd1-357cb00c4768
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix Twist Off
Version Model NumberTN-FX-8030
Catalog NumberTN-FX-8030
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
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
GS100819034023196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


[00819034023196]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-30
Device Publish Date2019-04-22

On-Brand Devices [FuzeFix Twist Off]

00819034023196TN-FX-8030 Depth Guage
00819034021864Twist Off Driver Stem Driver 2.0mm
00819034021857Twist Off Driver Stem Driver 2.5mm
00819034021840Twist Off Driver Breakaway Driver 2.0mm
00819034021833Twist Off Driver Breakaway Driver 2.5mm

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