FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094080674
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901075
Catalog number
32810
Device description
Welch Allyn Rigid Fiber-Optic Sigmoidoscope with Obturator; 19 mm x 15 cm
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
00732094080674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094080674007320940806747320940806740732094080674

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
00817655023106Welch Allyn, Inc.9011454197342019-10-23
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094319903Welch Allyn, Inc.9010114198322023-09-26
00732094326079Welch Allyn, Inc.9010069293-024-512023-08-25
00732094247138Welch Allyn, Inc.90103139500-TE2019-08-28
00732094247145Welch Allyn, Inc.90103139500-NP-TE2019-08-28
00732094272338Welch Allyn, Inc.90115211094-001-502020-03-24
00732094258905Welch Allyn, Inc.90113411012-014-502020-03-20
00732094307351Welch Allyn, Inc.9011454197512019-10-23
00732094307368Welch Allyn, Inc.9011454133792019-10-23
00732094307375Welch Allyn, Inc.9011454197332019-10-23
00732094258998Welch Allyn, Inc.901011036840-0052019-09-26
00732094272673Welch Allyn, Inc.901011036840-0062019-09-26
00817655020679Welch Allyn, Inc.90113411012-016-502019-09-26
00817655020686Welch Allyn, Inc.90113411012-016-512019-09-26
00732094296341Welch Allyn, Inc.90101211093-003-502019-06-11
00732094223910Welch Allyn, Inc.9011084112152023-08-24
00732094089226Welch Allyn, Inc.901020118402016-09-17
00732094089240Welch Allyn, Inc.901022118202016-09-17

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
00732094080629Welch Allyn, Inc.WELCH ALLYN, INC.KDM2016-09-17
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
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