DeRoyal

Primary DI
00749756173520
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-898
Device description
CUSTOM SIGMOIDOSCOPE
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756173525PackageGS150In Commercial Distribution
00749756173520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975617352550749756173525
00749756173520007497561735207497561735200749756173520

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video sigmoidoscope, reusableAn endoscope with a flexible 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), typically in relation to altered bowel habit, colonic cancer, or polyps. It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

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
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
50749756173525DeRoyalDEROYAL INDUSTRIES, INC.FAM2016-09-12