FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094200300
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901016
Catalog number
30200D
Device description
RECTAL INSUFFLATION BULB DISPOSABLE
Published
2020-01-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K770291000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K770291000SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125Welch Allyn, Inc.1977-02-18FAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732094200300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094200300007320942003007320942003000732094200300

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00732094183948Welch Allyn, Inc.90102211820-L2016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926945PENTAX MedicalPENTAX MEDICAL CORPORATIONFAM2026-08-25
04580826927058PENTAX MedicalPENTAX MEDICAL CORPORATIONFAM2026-08-25
04580826928611PENTAX MedicalPENTAX MEDICAL CORPORATIONFAM2026-08-25
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
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
00732094236958Welch Allyn, Inc.WELCH ALLYN, INC.FAM2016-09-20
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