Zavation Medical Products, LLC

GUDID 00842166187931

SIBI CAGE

ZAVATION LLC

Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Primary Device ID00842166187931
NIH Device Record Key8ad0c7fc-0d33-4193-bc8a-fa9b101a4bda
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation Medical Products, LLC
Version Model Number540-742710
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

Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com
Phone601.919.1119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100842166187931 [Primary]
GS100842166187931 [Primary]
GS100842166187931 [Primary]
GS100842166187931 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842166187931]

Moist Heat or Steam Sterilization


[00842166187931]

Moist Heat or Steam Sterilization


[00842166187931]

Moist Heat or Steam Sterilization


[00842166187931]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [Zavation Medical Products, LLC]

00842166195301SIBI Instrument Tray
00842166187023INSERTER
00842166187931SIBI CAGE

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