ZAVATION INSITU BENDER

GUDID 00197157014759

TIGER 2 INSITU BENDER Ø 5.5mm RIGHT

Zavation LLC

General external orthopaedic fixation system implantation kit, reusable
Primary Device ID00197157014759
NIH Device Record Key3cc7a606-061b-4cfd-96dc-c910214563b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameZAVATION INSITU BENDER
Version Model Number989-1028-R
Company DUNS069472800
Company NameZavation 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 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

Customer Support Contacts

Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157014759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


[00197157014759]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-11
Device Publish Date2025-06-03

On-Brand Devices [ZAVATION INSITU BENDER]

00197157014759TIGER 2 INSITU BENDER Ø 5.5mm RIGHT
00197157014742TIGER 2 INSITU BENDER Ø 5.5mm LEFT

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