FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094080629
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901075
Catalog number
35303
Device description
Welch Allyn 6.0 V Halogen Fiber-Optic Sigmoidoscope Set including Three Fiber-Optic Rigid Sigmoidoscopes with Obturators (#32410 15 mm x 15 cm, #32820 19 mm x 25 cm, #37023 23 mm x 7 cm), 30 cm Suction Tube (#30130), Insufflation Bulb (#30200), Fiber-Optic Light Head (#36019), Light Handle with 3.0 ft/0.9 m Cord (#73211), Power Transformer with 5.0
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDMSIGMOIDOSCOPE, RIGID, NON-ELECTRICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDMSigmoidoscope, Rigid, Non-ElectricalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094080629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094080629007320940806297320940806290732094080629

GMDN Terms#

Term, Definition table
TermDefinition
Rigid sigmoidoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine the structures and lining of the sigmoid colon and for indications of altered bowel habit, colonic cancer, or polyps. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
198227881
Device count
1
Premarket exempt
true
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
08033638800614Rectoscope equipmentSAPI MED SPAKDM2025-02-17
08033638800621Rectoscope equipmentSAPI MED SPAKDM2025-02-17
08033638801536Rectoscope equipmentSAPI MED SPAKDM2025-02-17
08033638800713Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638801550Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638800720Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638801567Rectoscope equipmentSAPI MED SPAKDM2023-07-27
08033638800225Grip for rectoscopeSAPI MED SPAKDM2016-11-30
08033638800164RectoscopeSAPI MED SPAKDM2016-11-25
08033638800188RectoscopeSAPI MED SPAKDM2016-11-25
08033638800201RectoscopeSAPI MED SPAKDM2016-11-25
08033638800249RectoscopeSAPI MED SPAKDM2016-11-25
08033638800263RectoscopeSAPI MED SPAKDM2016-11-25
08033638800171RectoscopeSAPI MED SPAKDM2016-11-25
08033638800195RectoscopeSAPI MED SPAKDM2016-11-25
08033638800218RectoscopeSAPI MED SPAKDM2016-11-25
08033638800256RectoscopeSAPI MED SPAKDM2016-11-25
08033638800270RectoscopeSAPI MED SPAKDM2016-11-25
00732094080636Welch Allyn, Inc.WELCH ALLYN, INC.KDM2016-09-17
00732094080643Welch Allyn, Inc.WELCH ALLYN, INC.KDM2016-09-17
00732094080650Welch Allyn, Inc.WELCH ALLYN, INC.KDM2016-09-17
00732094080667Welch Allyn, Inc.WELCH ALLYN, INC.KDM2016-09-17
00732094080674Welch Allyn, Inc.WELCH ALLYN, INC.KDM2016-09-17
00732094080681Welch Allyn, Inc.WELCH ALLYN, INC.KDM2016-09-17
00732094080698Welch Allyn, Inc.WELCH ALLYN, INC.KDM2016-09-17
00732094080902Welch Allyn, Inc.WELCH ALLYN, INC.KDM2016-09-17
00732094080919Welch Allyn, Inc.WELCH ALLYN, INC.KDM2016-09-17
00613970014856MONARCH DISPOSABLE ANOSCOPEMONARCH MOLDING, INC.KDM2016-09-14
00613970018908MONARCH DISPOSABLE ANOSCOPEMONARCH MOLDING, INC.KDM2016-09-14
00613970018915MONARCH DISPOSABLE ANOSCOPEMONARCH MOLDING, INC.KDM2016-09-14