Regento Regenerative Scaffold 202937-10

GUDID 00852108006510

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 ID00852108006510
NIH Device Record Key35af10dc-8b71-44c9-8fa5-bd074bb75951
Commercial Distribution Discontinuation2022-07-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegento Regenerative Scaffold
Version Model Number02-100-03-VTX
Catalog Number202937-10
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852108006510 [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

Devices Manufactured by CYTOPHIL, INC.

00856509002621 - Trab-X SB Synthetic Bone Matrix2020-03-23 Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of
00852108006275 - Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules2020-01-27 Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting m
00852108006282 - Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules2020-01-27 Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting m
00856509002638 - Trab-X SB Synthetic Bone Matrix2020-01-27 Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of
00852108006411 - Callisto Granules Beta-TCP Synthetic Bone Graft2019-12-12 Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intended to fill bony void or gaps of
00852108006138 - Implant Logistics Synthetic Biphasic Dental Bone Graft Granules2019-12-09 Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting m
00852108006107 - Implant Logistics Synthetic Biphasic Dental Bone Graft Granules2019-11-08 Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting m
00852108006114 - Implant Logistics Synthetic Biphasic Dental Bone Graft Granules2019-11-08 Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting m

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