FDA.report

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

Primary DI
00821925008755
Brand
Cleaning Brush To Be Used In Any Flexible Endoscope With a 3 Fr (1 mm
Company
Gyrus Acmi, Inc.
Model
CB-3115
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
00821925008755PackageGS12In Commercial Distribution
00821925038288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925008755008219250087558219250087550821925008755
00821925038288008219250382888219250382880821925038288

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00821925043916SOLTIVETFL-FBX150BS2024-08-01
00821925043930SOLTIVETFL-FBX200S2024-08-01
00821925043978SOLTIVETFL-FBX200BS2024-08-01
00821925043992SOLTIVETFL-FBX365S2024-08-01
00821925044074SOLTIVETFL-FBX940S2024-08-01
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002098USA Elite SystemEOS-HCF252024-07-25
00821925002111USA Elite SystemERIS-CF252024-07-25
00821925002128USA Elite SystemERIS-CF272024-07-25
00821925002159USA Elite SystemERLB-7.52024-07-25
00821925002166USA Elite SystemEROS-CF252024-07-25
00821925002173USA Elite SystemEROS-CF272024-07-25
00821925002586Gyrus ACMI1942024-07-25
00821925007482Gyrus ACMIRFG-31152024-07-25
00821925008076Bovie5686012024-07-25
00821925008083Bovie5686042024-07-25
00821925008458Bovie5686052024-07-25
00821925008908Gyrus ACMIG2152-322024-07-25
00821925009523IRRI-FLO I 59200002024-07-25
00821925011427DIEGO703390502024-07-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00724995233327DuoswiftUS EndoscopyMNL2026-03-12
00817169024989Pristine by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCMNL2026-03-05
10850075039002Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039033Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039057Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039071Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039095Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039118Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039125Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039156Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039194Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10850075039217Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10860002853106Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
00860002853192Venturi MicroDryerGI SCIENTIFIC LLCMNL2026-02-10
10860007020909Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10860007020947Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
20860007020968Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
00860007020971Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039149Venturi DryGI SCIENTIFIC LLCMNL2026-02-09
00190776415686MillenniumAvalign Technologies, Inc.MNL2026-02-04
00198506087370ELMED INCORPORATEDELMED INCORPORATEDMNL2026-01-07
G4533352003290PEAK MEDICALPeak Medical Distribution Inc.MNL2026-01-05
G4533353003310PEAK MEDICALPeak Medical Distribution Inc.MNL2026-01-05
00850067560227LaproClearSurgical Principals, IncMNL2025-12-11
00816185001165AquaBrush SystemTorvan Medical IncMNL2025-12-08
16936603228934Single Use Angulation Knob ExtenderYangzhou Fartley Medical Instrument Technology Co., LtdMNL2025-12-03
16936603231736Single-Use ErgoGrip Knob ExtenderYangzhou Fartley Medical Instrument Technology Co., LtdMNL2025-12-03
00198506018268ELMED INCORPORATEDELMED INCORPORATEDMNL2025-09-05
00198506084775ELMED INCORPORATEDELMED INCORPORATEDMNL2025-08-26
00198506084782ELMED INCORPORATEDELMED INCORPORATEDMNL2025-08-26