Callisto Granules Beta-TCP Synthetic Bone Graft VX-12020

GUDID 00852108006381

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 ID00852108006381
NIH Device Record Key32b4ae01-9ac5-4fb8-8fcb-8063e6428cfa
Commercial Distribution Discontinuation2019-11-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCallisto Granules Beta-TCP Synthetic Bone Graft
Version Model Number02-200-02-VEX
Catalog NumberVX-12020
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 Volume20 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852108006381 [Primary]

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-10-30

On-Brand Devices [Callisto Granules Beta-TCP Synthetic Bone Graft]

00852108006411Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend
00852108006404Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend
00852108006381Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend
00852108006367Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend

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