Zavation MALLET

GUDID 00197157049140

MALLET

Zavation LLC

General external orthopaedic fixation system implantation kit, reusable
Primary Device ID00197157049140
NIH Device Record Key98c57743-5493-4ccd-b5dd-c67920dd5054
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation MALLET
Version Model Number540-1017
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
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
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157049140 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

[00197157049140]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-07
Device Publish Date2024-10-30

Devices Manufactured by Zavation LLC

00197157019327 - Zavation Custom Inserter 2024-11-21 Custom Inserter
00197157019334 - Zavation CURVED CURETTE2024-11-21 CURVED CURETTE, 11ga, SHALLOW
00197157019624 - Zavation Custom Polyaxial Driver 2024-11-21 Custom Polyaxial Driver
00197157019631 - Zavation Pedicle Screw Head Assembly Tool2024-11-21 Pedicle Screw Head Assembly Tool/5.5,6.5, & 7.5
00197157019648 - Zavation Pedicle Screw Head Assembly Tool2024-11-21 Pedicle Screw Head Assembly Tool/4.5,8.5, & 9.5
00197157019655 - Zavation Pedicle Screw Head Assembly Tool2024-11-21 Pedicle Screw Head Assembly Tool/10.5, & 11.5
00842166130081 - Zavation Solid Standard Modular Screw2024-11-20 Solid Standard Modular Screw 10.5x110
00842166194809 - Zavation Modular Screw2024-11-20 Modular Screw 8.5x110
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