FuzeFix Twist Off CD-TW-3020

GUDID 00819034021864

Twist Off Driver Stem Driver 2.0mm

FUSION ORTHOPEDICS, LLC

Surgical screwdriver, reusable
Primary Device ID00819034021864
NIH Device Record Key8e57fc9a-9db3-4a51-8748-14bc2422c564
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuzeFix Twist Off
Version Model NumberCD-TW-3020
Catalog NumberCD-TW-3020
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
GS100819034021864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819034021864]

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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