Zavation

GUDID 00842166184640

11 Gauge Cement Delivery Cannula

ZAVATION LLC

Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit Balloon kyphoplasty kit
Primary Device ID00842166184640
NIH Device Record Keyd3cb7785-130c-4737-ad66-c2972ba28de4
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation
Version Model NumberVCF-1007-11
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
Phone601-919-1119
Emailinfo@zavation.com
Phone601-919-1119
Emailinfo@zavation.com
Phone601-919-1119
Emailinfo@zavation.com
Phone601-919-1119
Emailinfo@zavation.com
Phone601-919-1119
Emailinfo@zavation.com
Phone601-919-1119
Emailinfo@zavation.com
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
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]
GS100842166184640 [Primary]

FDA Product Code

NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty
NDNCement, Bone, Vertebroplasty

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


[00842166184640]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [Zavation]

00084216611481TLIF 30, 6deg -15
00842166195134Anterior IBF Tray
00842166195127Cervical Cage Tray
00842166195110Z-Link Cervical Tray
00842166195103Normandy Set Screw Caddy
00842166195097SI Screw Tray
008421661950801-2 Level Cervical Plate Tray
00842166195073Z-Direct Instrument Tray
00842166195066Normandy VBR System Tray
00842166195059EZ Plate Cervical Tray
00842166195042Z-Span Lateral System Tray
00842166195035Z-Span Anterior System Tray
00842166195028Z-Link Lumbar Tray
00842166195011MIS Instrument Tray
00842166195004Cervical Plate Tray
00842166182684LEIF Sizer 9 x 27 x 5 deg - 13
00842166182677LEIF Sizer 9 x 27 x 5 deg - 12
00842166182660LEIF Sizer 9 x 27 x 5 deg - 11
00842166182653LEIF Sizer 9 x 27 x 5 deg - 10
00842166182646LEIF Sizer 9 x 27 x 5 deg - 09
00842166182639LEIF Sizer 9 x 27 x 5 deg - 08
00842166182622LEIF Sizer 9 x 23 x 5 deg - 13
00842166182615LEIF Sizer 9 x 23 x 5 deg - 12
00842166182608LEIF Sizer 9 x 23 x 5 deg - 11
00842166182592LEIF Sizer 9 x 23 x 5 deg - 10
00842166182585LEIF Sizer 9 x 23 x 5 deg - 09
00842166182578LEIF Sizer 9 x 23 x 5 deg - 08
00842166182325Custom Paddle
00842166182318Custom Paddle
00842166182301Custom Paddle
00842166182295T-Handle, Ratcheting
00842166182004PEDICLE FINDER, DUCKBILL, CURVED, ZAVATION
00842166181991PEDICLE FINDER, ZAVATION DUCKBILL, STRAIGHT
00842166181984Polyaxial Screwdriver, 2.5mm straight hex - AO Handle
00842166181977K-Wire, Blunt, Smooth
00842166181960Shim
00842166181953Calipers - MIS
00842166181946Custom Implant Holder
00842166181939TORQ LMT, SM T-HDL, CSTM HEX
00842166181922T-HDL, HEX DRIVER, ZAVATION
00842166181915Removal Tool
00842166181793Graft Pusher
00842166181786Graft Funnel
00842166181779Base Rotative
00842166181762Table Clamp w/o Base
0084216618175521mm Dilator
0084216618174819mm Dilator
0084216618173117mm Dilator
0084216618172415mm Dilator
0084216618171713mm Dilator

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