Cyotplast™ RTMFoam

GUDID D765RTMFOAM100

General oral wound dressing, animal-derived

Primary Device ID	D765RTMFOAM100
NIH Device Record Key	525711e2-5a8c-4b81-9f32-7aa9577a0dad
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cyotplast™ RTMFoam
Version Model Number	RTMFOAM10
Company DUNS	123853058
Company Name	Osteogenics Biomedical Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	D765RTMFOAM100 [Primary]
HIBCC	D765RTMFOAM101 [Package] Package: [10 Units] In Commercial Distribution

KGN	Dressing, Wound, Collagen

Steralize Prior To Use	false
Device Is Sterile	true

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D765GC4019451 - X-Gut™ Chromic Gut Suture	2025-09-09 Chromic Gut, USP 4-0, 19 mm 3/8 Circle Reverse Cutting Needle
D765GC4019751 - X-Gut™ Chromic Gut Suture	2025-09-09 Chromic Gut, USP 4-0, 19 mm 3/8 Circle Reverse Cutting Needle
D765GC4019P451 - X-Gut™ Chromic Gut Suture	2025-09-09 Chromic Gut, USP 4/0, 19 mm 3/8 Circle Precision Point Reverse Cutting Needle