FDA.reportPublic FDA data

Cygnus

Primary DI
00814707023824
Brand
Cygnus
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
ASO3E160
Catalog number
ASO3E160
Device description
"ERCP160 SET WITH ONE EACH OF: ASOA3, ASOA5, ASOA6, THREADED CONNECTOR, AND 2.5"" SOFT TUBING"
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00814707023824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814707023824008147070238248147070238240814707023824

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic device drying tubingA length of flexible tube with connectors intended to channel air from an endoscope dryer to an endoscopic device (e.g., irrigation tubing or bottle) for drying after washing/disinfection. It is not intended to be used during a medical procedure. This is a reusable device.

Regulatory Flags#

DUNS number
027680821
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840113233762Bovie Derm 1022026-05-11
00607151010263BovieA1250SA1250S2018-02-23
00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

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
00840113299171CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-09