Callisto Granules Beta-TCP Synthetic Bone Graft - Synthetic bone graft substitute in particulate - CYTOPHIL, INC.

Duns Number:024222105

Device Description: Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate 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.

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More Product Details

Catalog Number

VX-23310

Brand Name

Callisto Granules Beta-TCP Synthetic Bone Graft

Version/Model Number

02-100-03-VEX

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 12, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

b1663e09-5467-4713-8931-5b89a2d7dcc7

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

October 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CYTOPHIL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 35