FDA.reportPublic FDA data

CYGNUS

Primary DI
00843356102895
Brand
CYGNUS
Company
CYGNUS MEDICAL L.L.C.
Model
ASO6E160
Device description
"EUS Raidial160 SET WITH ONE EACH OF: ASOA3 ASOA9 ASOA6 2.5"" SOFT TUBE 100 PER CASE"
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JRJUnit, Drying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRJUnit, DryingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843356102895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843356102895008433561028958433561028950843356102895

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope dryerAn electrically-powered assembly of devices designed to dry the internal channel of an endoscope after washing, and to maintain dryness during storage, to prevent bacterial growth and endoscope deterioration. It consists of a user interface, a control unit, tubing/connectors for attaching to the endoscope, and may incorporate either an internal air pump or a connection for standard medical air supply; it may be designed for use on a bench or in a cabinet.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103169095
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843356102932CYGNUSLTS12122026-02-16
00843356102949CYGNUSLTS12162026-02-16
00843356102956CYGNUSLTS24242026-02-16
00843356102963CYGNUSASO3E1602026-01-15
00843356102888CYGNUSASO3E1902025-12-16
00843356102857CYGNUSCCL5002025-07-11
00843356102864CYGNUSSTR5002025-07-11
00843356101812Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12GIC190R2024-12-31
00843356101829Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12GIC270R2024-12-31
10843356102694CYGNUSGTG-A-20002024-12-11
00843356102741CYGNUSEC03082024-11-20
00843356102758CYGNUSEC0308-SI2024-11-20
00843356102765CYGNUSEC06122024-11-20
00843356102772CYGNUSEC0612-SI2024-11-20
00843356102789CYGNUSEC07132024-11-20
00843356102796CYGNUSEC0713-SI2024-11-20
90843356102744CYGNUSEC03082024-11-20
90843356102751CYGNUSEC0308-SI2024-11-20
90843356102768CYGNUSEC06122024-11-20
90843356102775CYGNUSEC0612-SI2024-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20840113298758CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-20
10840113298638CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
10840113299482CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298642CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298765CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298772CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298796CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298802CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298819CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298895CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298901CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298994CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299007CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299014CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299021CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299052CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299083CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299090CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299106CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299120CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299151CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
10840113298928CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
10840113298980CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298932CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298949CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298956CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298963CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298970CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113299168CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
00814707023824CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10