RegenOsteo Orthopedic Beta-TCP 02-050-02-RGO

GUDID 00856509002690

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 ID00856509002690
NIH Device Record Keya4f7246e-f275-4d9c-86cb-9122620e7711
Commercial Distribution Discontinuation2019-11-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRegenOsteo Orthopedic Beta-TCP
Version Model Number02-050-02-RGO
Catalog Number02-050-02-RGO
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 Volume5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856509002690 [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 [RegenOsteo Orthopedic Beta-TCP]

00856509002706Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend
00856509002690Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate intend

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