Zavation CUSTOM DRILL

GUDID 00197157029289

CUSTOM DRILL

Zavation LLC

Manual surgical rotary handpiece, reusable
Primary Device ID00197157029289
NIH Device Record Key77fa10b0-295f-4ab5-bc82-4793af75af36
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation CUSTOM DRILL
Version Model NumberZAV-1364-35
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157029289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

[00197157029289]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-11-14
Device Publish Date2024-09-05

Devices Manufactured by Zavation LLC

00197157071400 - ZAVATION ROD BENDER2025-09-23 INSITU BENDER - RIGHT 6.0 ROD
00197157071417 - ZAVATION ROD BENDER2025-09-23 INSITU BENDER - LEFT 6.0 ROD
00197157071455 - ZAVATION CADDY2025-09-23 TIGER 2 DEFORMITY IMPLANTS - HOOKS CADDY
00197157071462 - ZAVATION CADDY2025-09-23 TIGER 2 DEFORMITY IMPLANTS - FRACTURE SCREW CADDY (STANDARD OR CANNULATED)
00197157071479 - ZAVATION CADDY2025-09-23 TIGER 2 DEFORMITY IMPLANTS - FRACTURE SCREW- STANDARD LID
00197157071486 - ZAVATION CADDY2025-09-23 TIGER 2 DEFORMITY IMPLANTS - FRACTURE SCREW- CANNULATED LID
00197157071493 - ZAVATION CADDY2025-09-23 TIGER 2 DEFORMITY IMPLANTS - BIASED ANGLE SCREW CADDY (STANDARD OR REDUCTION)
00197157071509 - ZAVATION CADDY LID2025-09-23 TIGER 2 DEFORMITY IMPLANTS - BIASED ANGLE SCREW CADDY LID
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