Zavation ZV Graft Beta-TCP Synthetic Bone Graft 02-030-03-ZVG

GUDID 00856509002959

Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

CYTOPHIL, INC.

Bone matrix implant, synthetic
Primary Device ID00856509002959
NIH Device Record Keyb575e66e-20a5-4694-98a2-468559f51a7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation ZV Graft Beta-TCP Synthetic Bone Graft
Version Model Number02-030-03-ZVG
Catalog Number02-030-03-ZVG
Company DUNS024222105
Company NameCYTOPHIL, INC.
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

Device Dimensions

Total Volume3 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween -17 Degrees Celsius and 48 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856509002959 [Primary]

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-07
Device Publish Date2019-10-30

On-Brand Devices [Zavation ZV Graft Beta-TCP Synthetic Bone Graft]

00856509002959Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend
00856509002942Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend

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