Cyotplast™ RTMFoam

GUDID D765RTMFOAM100

Absorbable Dental Wound Dressing

Osteogenics Biomedical Inc

General oral wound dressing, animal-derived
Primary Device IDD765RTMFOAM100
NIH Device Record Key525711e2-5a8c-4b81-9f32-7aa9577a0dad
Commercial Distribution StatusIn Commercial Distribution
Brand NameCyotplast™ RTMFoam
Version Model NumberRTMFOAM10
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

Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 Centimeter
Width2 Centimeter
Length4 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
HIBCCD765RTMFOAM100 [Primary]
HIBCCD765RTMFOAM101 [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

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