Zavation INSERTER INNER SHAFT

GUDID 00197157049898

INSERTER INNER SHAFT

Zavation LLC

Orthopaedic inorganic implant inserter/extractor, reusable
Primary Device ID00197157049898
NIH Device Record Keyac077e42-847b-43dd-aa31-fef4fb781076
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation INSERTER INNER SHAFT
Version Model Number540-1000-2
Company DUNS069472800
Company NameZavation LLC
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157049898 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


[00197157049898]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-21
Device Publish Date2025-01-13

Devices Manufactured by Zavation LLC

00197157050139 - Zavation CUSTOM SCREW HEIGHT ADJUSTER 2025-02-06 CUSTOM 1/4 DRIVE SCREW HEIGHT ADJUSTER T-27
00197157049881 - Zavation INSERTER OUTTER SHAFT2025-01-21 INSERTER OUTTER SHAFT
00197157049898 - Zavation INSERTER INNER SHAFT2025-01-21INSERTER INNER SHAFT
00197157049898 - Zavation INSERTER INNER SHAFT2025-01-21 INSERTER INNER SHAFT
00197157049904 - Zavation STRAIGHT ROD2025-01-21 STRAIGHT ROD
00197157049911 - Zavation STRAIGHT ROD2025-01-21 STRAIGHT ROD
00197157049928 - Zavation CUSTOM DRILL GUIDE2025-01-21 CUSTOM DRILL GUIDE
00197157049935 - Zavation CUSTOM CERVICAL DRILL2025-01-21 CUSTOM CERVICAL DRILL
00197157049942 - Zavation CERVICAL SPLIT DRIVER2025-01-21 2.5mm CERVICAL SPLIT DRIVER

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