FDA.report

Cleaning Brush To Be Used In Any Endoscope With a 3 Fr (1 mm) Channel

Primary DI
00821925008762
Brand
Cleaning Brush To Be Used In Any Endoscope With a 3 Fr (1 mm) Channel
Company
Gyrus Acmi, Inc.
Model
CB-365
Published
2018-09-13
Public version status
New
Distribution status
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
MNLACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00821925008762PackageGS12In Commercial Distribution
00821925038295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925008762008219250087628219250087620821925008762
00821925038295008219250382958219250382950821925038295

GMDN Terms

TermDefinition
Endoscope cleaning brush, reusableA device used to remove dirt or debris from the working channel(s) and irregular surface of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube or metal coil with plastic bristles. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
007198742
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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