ZAVATION DRIVER

GUDID 00197157014445

TIGER 2 REDUCTION TAB DRIVER, CANNULATED GLOBUS POWEREASE, LOCKING

Zavation LLC

Orthopaedic implant driver
Primary Device ID00197157014445
NIH Device Record Key08f2f5a6-b363-4b14-9d52-c94abd3b1786
Commercial Distribution StatusIn Commercial Distribution
Brand NameZAVATION DRIVER
Version Model Number989-1059-CPRL
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
GS100197157014445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

Moist Heat or Steam Sterilization

[00197157014445]

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 DRIVER]

00197157014469TIGER 2 REDUCTION TAB DRIVER, CANNULATED GLOBUS HUDSON, LOCKING
00197157014452TIGER 2 REDUCTION TAB DRIVER, CANNULATED GLOBUS JACOBS, LOCKING
00197157014445TIGER 2 REDUCTION TAB DRIVER, CANNULATED GLOBUS POWEREASE, LOCKING
00197157014438TIGER 2 REDUCTION TAB DRIVER, GLOBUS HUDSON, LOCKING
00197157014421TIGER 2 REDUCTION TAB DRIVER, GLOBUS JACOBS, LOCKING
00197157014414TIGER 2 REDUCTION TAB DRIVER, GLOBUS POWEREASE, LOCKING
00197157014407TIGER 2 POLYAXIAL DRIVER, CANNULATED GLOBUS HUDSON, LOCKING
00197157014391TIGER 2 POLYAXIAL DRIVER, CANNULATED GLOBUS JACOBS, LOCKING
00197157014384TIGER 2 POLYAXIAL DRIVER, CANNULATED GLOBUS POWEREASE, LOCKING
00197157014377TIGER 2 POLYAXIAL DRIVER, GLOBUS HUDSON, LOCKING
00197157014360TIGER 2 POLYAXIAL DRIVER, GLOBUS JACOBS, LOCKING
00197157014353TIGER 2 POLYAXIAL DRIVER, GLOBUS POWEREASE, LOCKING
00197157014346TIGER 2 REDUCTION TAB DRIVER, CANNULATED GLOBUS HUDSON
00197157014339TIGER 2 REDUCTION TAB DRIVER, CANNULATED GLOBUS JACOBS
00197157014322TIGER 2 REDUCTION TAB DRIVER, CANNULATED GLOBUS POWEREASE
00197157014315TIGER 2 REDUCTION TAB DRIVER, GLOBUS HUDSON
00197157014308TIGER 2 REDUCTION TAB DRIVER, GLOBUS JACOBS
00197157014292TIGER 2 REDUCTION TAB DRIVER, GLOBUS POWEREASE
00197157014285TIGER 2 POLYAXIAL DRIVER, CANNULATED GLOBUS HUDSON
00197157014278TIGER 2 POLYAXIAL DRIVER, CANNULATED GLOBUS JACOBS
00197157014261TIGER 2 POLYAXIAL DRIVER, CANNULATED GLOBUS POWEREASE
00197157014254TIGER 2 POLYAXIAL DRIVER, GLOBUS HUDSON
00197157014247TIGER 2 POLYAXIAL DRIVER, GLOBUS JACOBS
00197157014230TIGER 2 POLYAXIAL DRIVER, GLOBUS POWEREASE
00197157014223TIGER 2 SHANK DRIVER, DIAL ACTION, 215mm CANNULATED GLOBUS JACOBS
00197157014216TIGER 2 SHANK DRIVER, LEVER ACTION, 215mm CANNULATED GLOBUS JACOBS
00197157014209TIGER 2 SHANK DRIVER, DIAL ACTION, 215mm CANNULATED GLOBUS POWEREASE
00197157014193TIGER 2 SHANK DRIVER, LEVER ACTION, 215mm CANNULATED GLOBUS POWEREASE
00197157014186TIGER 2 SHANK DRIVER, DIAL ACTION, 215mm GLOBUS JACOBS
00197157014179TIGER 2 SHANK DRIVER, LEVER ACTION, 215mm GLOBUS JACOBS
00197157014162TIGER 2 SHANK DRIVER, DIAL ACTION, 215mm GLOBUS POWEREASE
00197157014155TIGER 2 SHANK DRIVER, LEVER ACTION, 215mm GLOBUS POWEREASE
00197157021559Final Locking Driver
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