Zavation Custom Polyaxial Driver

GUDID 00197157019624

Custom Polyaxial Driver

Zavation LLC

Orthopaedic implant driver
Primary Device ID00197157019624
NIH Device Record Keyf1fc37c2-f4f7-40d1-ab56-0629b58f24d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation Custom Polyaxial Driver
Version Model NumberZAV-1354
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 Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157019624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


[00197157019624]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-21
Device Publish Date2024-11-13

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00197157049935 - Zavation CUSTOM CERVICAL DRILL2025-01-21 CUSTOM CERVICAL DRILL
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