FDA.reportPublic FDA data

N/A

Primary DI
04961333243303
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
KUMCS-3025SK
Device description
CLEANING BRUSHES 2 PER PACK
Published
2018-03-14
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

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333243303PrimaryGS10
14961333243300Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333243303049613332433034961333243303
1496133324330014961333243300

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length250Centimeter
Lumen/Inner Diameter1.8Millimeter
Outer Diameter3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;High-level Disinfectant;Sound Waves

Regulatory Flags#

DUNS number
083211284
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333255696Digital Capture v3.7.09380 2025-09-12
04961333255979 MICROPHONE ASSAY KIT6651 2025-07-21
04961333255986Disposables Kit6650 2025-07-21
04961333255016LARYNGOSTROBOSCOPE95002025-04-25
04961333255702LARYNGOSTROBOSCOPE9500LX2025-04-25
04961333255719LARYNGOSTROBOSCOPE9500MC2025-04-25
04961333255726LARYNGOSTROBOSCOPE9500FS2025-04-25
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333254309MULTI-SPEECH3706-12023-08-25
04961333248117Pentax of America93802022-11-04
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333248001ENDOPRO REVIEW WORKSTATIONKBM68344NA2020-03-26
04961333248018ENDOPRO NETWORK CAPTURE WORKSTATIONKBM683452020-03-26
04961333248025ENDOPRO STANDALONEC CAPTURE WORKSTATIONKBM683462020-03-26
04961333244355BRANDMAXU-5LH2018-03-15
04961333244188N/AOS-H52018-03-15

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