Cytoplast™ RTMPlug

GUDID D765RTMPLUG100

Absorbable Dental Wound Dressing

Osteogenics Biomedical Inc

General oral wound dressing, animal-derived
Primary Device IDD765RTMPLUG100
NIH Device Record Key345945be-e9aa-47d9-b3d4-2243eb58a597
Commercial Distribution StatusIn Commercial Distribution
Brand NameCytoplast™ RTMPlug
Version Model NumberRTMPLUG10
Company DUNS123853058
Company NameOsteogenics Biomedical 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

Customer Support Contacts

Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com
Phone(888) 796-1923
Emailsales@osteogenics.com

Device Dimensions

Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter
Width1 Centimeter
Length2 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD765RTMPLUG100 [Primary]
HIBCCD765RTMPLUG101 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

KGNDressing, Wound, Collagen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-12
Device Publish Date2016-12-09

Devices Manufactured by Osteogenics Biomedical Inc

D765ZD1520TK0 - ZDERM™2024-05-21 Collagen Soft Tissue Matrix
D765ZD2030TK0 - ZDERM™2024-05-21 Collagen Soft Tissue Matrix
D765ZD3040TK0 - ZDERM™2024-05-21 Collagen Soft Tissue Matrix
D765RTM15200 - Cyotplast™ RTM Collagen2023-09-12 Resorbable Bovine Collagen Barrier Membrane, 15 mm x 20 mm
D765RTM152010 - CYTOPLAST RTM COLLAGEN2023-09-12 Resorbable Bovine Collagen Barrier Membrane, 15mm x 20mm, Sterile, Contents: 1 Membrane
D765RTM20300 - Cyotplast™ RTM Collagen2023-09-12 Resorbable Bovine Collagen Barrier Membrane, 20 mm x 30 mm
D765RTM203010 - CYTOPLAST RTM COLLAGEN2023-09-12 Resorbable Bovine Collagen Barrier Membrane, 20mm x 30mm, Sterile, Contents: 1 Membrane
D765RTM30400 - Cyotplast™ RTM Collagen2023-09-12 Resorbable Bovine Collagen Barrier Membrane, 30 mm x 40 mm

Trademark Results [Cytoplast]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CYTOPLAST
CYTOPLAST
87284533 5394296 Live/Registered
Osteogenics Biomedical, Inc.
2016-12-29
CYTOPLAST
CYTOPLAST
75379702 2208908 Dead/Cancelled
Osteogenics Biomedical, Inc.
1997-10-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.