FDA.report

COE FOAM™ II

Primary DI
D6585512222
Brand
COE FOAM™ II
Company
Gc America Inc.
Model
551222
Catalog number
551222
Device description
COE FOAM™ II Aerosol Can (18 oz.)
Published
2017-02-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LRJDisinfectant, medical devices

Product Code Classifications

CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6585512222PackageHIBCC12Not in Commercial Distribution
D6585512221PrimaryHIBCC0

GMDN Terms

TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags

DUNS number
005473608
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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