FDA.report

Cytoplast RTM Foam

Primary DI
D765RTMFOAM101
Brand
Cytoplast RTM Foam
Company
Osteogenics Biomedical Inc
Model
RTMFOAM10
Catalog number
RTMFOAM10
Device description
Absorbable Dental Wound Dressing (10 per box)
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KGNDressing, Wound, Collagen

Product Code Classifications

CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D765RTMFOAM101PrimaryHIBCC0
D765RTMFOAM100Unit of UseHIBCC0

GMDN Terms

TermDefinition
General oral wound dressing, animal-derivedA collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Length4Centimeter
Width2Centimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
(888) 796-1923sales@osteogenics.com

Regulatory Flags

DUNS number
123853058
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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