FDA.reportPublic FDA data

CONMED

Primary DI
20653405054037
Brand
CONMED
Company
Conmed Corporation
Model
001619
Catalog number
001619
Device description
CONMED LARGE COMBINATION CLEANING BRUSH
Published
2020-09-24
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
true

Contact Domains#

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
20653405054037PackageGS1100In Commercial Distribution
10653405054030PrimaryGS10
00653405054033Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340505403720653405054037
1065340505403010653405054030
00653405054033006534050540336534050540330653405054033

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning brush/tool, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length230Centimeter
Outer Diameter2Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
100
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
20653405037573CONMEDPCD10PCD102016-09-24
10653405063797CONMED75200752002026-03-24
00845854035590CONCEPTESA-5190ESA-51902026-03-24
10845854041116POWERPROPRO2000PRO20002026-03-24
10845854041291CONMEDLS7501LS75012026-03-24
00653405014952POOLE903507090350702026-03-24
20653405017759CONMEDD8324D83242026-03-24
20653405017766CONMEDD8324IID8324II2026-03-24
20653405019777CONMEDDA36-03DA36-032026-03-24
20653405022821CONMEDFSR1303FSR13032026-03-24
20653405022838CONMEDFSR1311FSR13112026-03-24
20653405022951CONMEDFSR1370FSR13702026-03-24
20653405023057CONMEDFSR1534FSR15342026-03-24
20653405023071CONMEDFSR1539FSR15392026-03-24
20653405023163CONMEDFSR1590FSR15902026-03-24
20653405023170CONMEDFSR1590-20FSR1590-202026-03-24
20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24

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Primary DI, Brand, Company table
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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
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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