ZAVATION SCREWDRIVER

GUDID 00197157013509

TIGER 2 POLYAXIAL SCREWDRIVER LOCKING CANNULATED NAVLOCK HUDSON

Zavation LLC

Surgical screwdriver, reusable
Primary Device ID00197157013509
NIH Device Record Key33563b98-02a4-437b-abe7-72525be458d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameZAVATION SCREWDRIVER
Version Model Number989-1019-CHL
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157013509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

[00197157013509]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-10
Device Publish Date2025-06-02

On-Brand Devices [ZAVATION SCREWDRIVER]

00197157014148TIGER 2 REDUCTION TAB SCREWDRIVER 215mm OL LOCKING CANNULATED POWEREASE
00197157014025TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL LOCKING CANNULATED POWEREASE
00197157014018TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL CANNULATED POWEREASE
00197157014001TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL LOCKING CANNULATED JACOBS
00197157013998TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL CANNULATED JACOBS
00197157013981TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL LOCKING CANNULATED HUDSON
00197157013974TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL CANNULATED HUDSON
00197157013967TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL LOCKING POWEREASE
00197157013950TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL POWEREASE
00197157013943TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL LOCKING JACOBS
00197157013936TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL JACOBS
00197157013929TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL LOCKING HUDSON
00197157013912TIGER 2 REDUCTION TAB SCREWDRIVER 150mm OL HUDSON
00197157013905TIGER 2 REDUCTION TAB SCREWDRIVER LOCKING CANNULATED NAVLOCK POWEREASE
00197157013899TIGER 2 REDUCTION TAB SCREWDRIVER CANNULATED NAVLOCK POWEREASE
00197157013882TIGER 2 REDUCTION TAB SCREWDRIVER LOCKING CANNULATED NAVLOCK JACOBS
00197157013875TIGER 2 REDUCTION TAB SCREWDRIVER CANNULATED NAVLOCK JACOBS
00197157013868TIGER 2 REDUCTION TAB SCREWDRIVER LOCKING CANNULATED NAVLOCK HUDSON
00197157013851TIGER 2 REDUCTION TAB SCREWDRIVER CANNULATED NAVLOCK HUDSON
00197157013844TIGER 2 REDUCTION TAB SCREWDRIVER LOCKING NAVLOCK POWEREASE
00197157013837TIGER 2 REDUCTION TAB SCREWDRIVER NAVLOCK POWEREASE
00197157013820TIGER 2 REDUCTION TAB SCREWDRIVER LOCKING NAVLOCK JACOBS
00197157013813TIGER 2 REDUCTION TAB SCREWDRIVER NAVLOCK JACOBS
00197157013806TIGER 2 REDUCTION TAB SCREWDRIVER LOCKING NAVLOCK HUDSON
00197157013790TIGER 2 REDUCTION TAB SCREWDRIVER NAVLOCK HUDSON
00197157013783TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL LOCKING CANNULATED POWEREASE
00197157013776TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL CANNULATED POWEREASE
00197157013769TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL LOCKING CANNULATED JACOBS
00197157013752TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL CANNULATED JACOBS
00197157013745TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL LOCKING CANNULATED HUDSON
00197157013738TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL CANNULATED HUDSON
00197157013721TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL POWEREASE
00197157013714TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL LOCKING POWEREASE
00197157013707TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL LOCKING JACOBS
00197157013691TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL JACOBS
00197157013684TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL LOCKING HUDSON
00197157013677TIGER 2 POLYAXIAL SCREWDRIVER 215mm OL HUDSON
00197157013660TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL LOCKING CANNULATED POWEREASE
00197157013653TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL CANNULATED POWEREASE
00197157013646TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL LOCKING CANNULATED JACOBS
00197157013639TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL CANNULATED JACOBS
00197157013622TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL LOCKING CANNULATED HUDSON
00197157013615TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL CANNULATED HUDSON
00197157013608TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL LOCKING POWEREASE
00197157013592TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL POWEREASE
00197157013585TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL LOCKING JACOBS
00197157013578TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL JACOBS
00197157013561TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL LOCKING HUDSON
00197157013554TIGER 2 POLYAXIAL SCREWDRIVER 150mm OL HUDSON
00197157013547TIGER 2 POLYAXIAL SCREWDRIVER LOCKING CANNULATED NAVLOCK POWEREASE
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.