FDA.reportPublic FDA data

Welch Allyn, Inc.

Primary DI
00732094080612
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901075
Catalog number
35323
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 ft/1.2 m Cord, Two Halogen Replacement Lamps (#07800-U), Hard Storage Case (#05391-U); 230 V, 50 Hz AC, IEC Plug Type-E/F
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
DLXHEMAGGLUTINATION INHIBITION, BARBITURATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLXHemagglutination Inhibition, BarbiturateClinical Toxicology2

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
00732094080612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094080612007320940806127320940806120732094080612

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
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