FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094236958
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901076
Catalog number
411865
Device description
DISPOSABLE ANO SHELF BOX
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAMsigmoidoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAMSigmoidoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094144024PackageGS14In Commercial Distribution
00732094236958PrimaryGS10
00732094236965Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094144024007320941440247320941440240732094144024
00732094236958007320942369587320942369580732094236958
00732094236965007320942369657320942369650732094236965

GMDN Terms#

Term, Definition table
TermDefinition
Optical anoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834gdsn_support@MyHillRom.onmicrosoft.com

Regulatory Flags#

DUNS number
198227881
Device count
25
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094335392Welch Allyn, Inc.90105875RT2022-10-03
00732094335422Welch Allyn, Inc.90105874RT2021-08-25
00732094335439Welch Allyn, Inc.90105874RE2021-08-25
00732094335446Welch Allyn, Inc.90105873RT2021-09-28
00732094335453Welch Allyn, Inc.90105873RE2020-05-15
00732094338751Welch Allyn, Inc.90105874WX2020-08-26
00732094338768Welch Allyn, Inc.90105874WT2020-08-26
00732094338775Welch Allyn, Inc.90105874WE2020-08-26
00732094335385Welch Allyn, Inc.90105875RX2023-04-26
00732094335408Welch Allyn, Inc.90105875RE2023-04-26
00732094335415Welch Allyn, Inc.90105874RX2023-04-26
00732094209167Welch Allyn, Inc.90105875WT-B2017-12-05
00732094209334Welch Allyn, Inc.90105875MX-B2017-12-05
00732094209372Welch Allyn, Inc.90105875MT-B2017-12-05
00732094209518Welch Allyn, Inc.90105875CT-B2017-12-05
00732094209570Welch Allyn, Inc.90105875CE-B2017-12-05
00732094209679Welch Allyn, Inc.90105874MT-B2017-12-05
00732094209792Welch Allyn, Inc.90105874CX-B2017-12-05
00732094209860Welch Allyn, Inc.90105874CT-B2017-12-05
00732094209921Welch Allyn, Inc.90105874CE-B2017-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732094139051Welch Allyn, Inc.WELCH ALLYN, INC.FAM2023-08-18
00732094139075Welch Allyn, Inc.WELCH ALLYN, INC.FAM2023-08-18
00732094080940Welch Allyn, Inc.WELCH ALLYN, INC.FAM2023-08-17
00732094080957Welch Allyn, Inc.WELCH ALLYN, INC.FAM2023-08-17
00732094080964Welch Allyn, Inc.WELCH ALLYN, INC.FAM2023-08-17
04961333115303PENTAXHOYA CORPORATIONFAM2023-07-31
04547410436501FUJIFILMFUJIFILM CORPORATIONFAM2021-04-27
00732094080384Welch Allyn, Inc.WELCH ALLYN, INC.FAM2021-04-26
00732094080391Welch Allyn, Inc.WELCH ALLYN, INC.FAM2021-04-14
00732094200300Welch Allyn, Inc.WELCH ALLYN, INC.FAM2020-01-16
00732094079678Welch Allyn, Inc.WELCH ALLYN, INC.FAM2018-03-01
00732094080933Welch Allyn, Inc.WELCH ALLYN, INC.FAM2018-03-01
04961333070831PENTAXHOYA CORPORATIONFAM2017-04-07
04961333071425PENTAXHOYA CORPORATIONFAM2017-04-07
04961333228164PENTAXHOYA CORPORATIONFAM2017-04-07
04961333232635VIDEO SIGMOIDOSCOPEPENTAX OF AMERICA, INC.FAM2017-04-06
04961333232642VIDEO SIGMOIDOSCOPEPENTAX OF AMERICA, INC.FAM2017-04-06
04547410330977FUJIFILMFUJIFILM CORPORATIONFAM2016-12-14
04547410333299FUJIFILMFUJIFILM CORPORATIONFAM2016-12-14
04048551084373n.a.Karl Storz GmbH & Co. KGFAM2016-09-23
00732094144024Welch Allyn, Inc.WELCH ALLYN, INC.FAM2016-09-20
00732094106046Welch Allyn, Inc.WELCH ALLYN, INC.FAM2016-09-19
00732094106060Welch Allyn, Inc.WELCH ALLYN, INC.FAM2016-09-17
00732094144000Welch Allyn, Inc.WELCH ALLYN, INC.FAM2016-09-17
00749756173520DeRoyalDEROYAL INDUSTRIES, INC.FAM2016-09-12
50749756173525DeRoyalDEROYAL INDUSTRIES, INC.FAM2016-09-12