Zavation CURVED CURETTE

GUDID 00197157019334

CURVED CURETTE, 11ga, SHALLOW

Zavation LLC

Balloon kyphoplasty kit
Primary Device ID00197157019334
NIH Device Record Key66e26b40-3a5f-4b73-bcfe-eeff8663c5af
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation CURVED CURETTE
Version Model NumberVCF-CCUR-11S
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 Datetrue
Expiration Datetrue
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
GS100197157019334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDNCement, Bone, Vertebroplasty

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

[00197157019334]

Ethylene Oxide

Device Entry Metadata

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

Devices Manufactured by Zavation LLC

00197157049881 - Zavation INSERTER OUTTER SHAFT2025-01-21 INSERTER OUTTER SHAFT
00197157049898 - Zavation INSERTER INNER SHAFT2025-01-21 INSERTER INNER SHAFT
00197157049904 - Zavation STRAIGHT ROD2025-01-21 STRAIGHT ROD
00197157049911 - Zavation STRAIGHT ROD2025-01-21 STRAIGHT ROD
00197157049928 - Zavation CUSTOM DRILL GUIDE2025-01-21 CUSTOM DRILL GUIDE
00197157049935 - Zavation CUSTOM CERVICAL DRILL2025-01-21 CUSTOM CERVICAL DRILL
00197157049942 - Zavation CERVICAL SPLIT DRIVER2025-01-21 2.5mm CERVICAL SPLIT DRIVER
00197157049843 - Zavation PEDICLE AWL2025-01-14 PEDICLE AWL
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