FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756029389
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-1020
Catalog number
32-1020
Device description
Custom Slides w/Gauze
Published
2021-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KEWSLIDES, MICROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756029385PackageGS12In Commercial Distribution
50749756029389PackageGS1100In Commercial Distribution
00749756029384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975602938530749756029385
5074975602938950749756029389
00749756029384007497560293847497560293840749756029384

GMDN Terms#

Term, Definition table
TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10810050855850Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855867Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855874Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855881Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855898Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855836Microscope SlidesTYPENEX MEDICAL LLCKEW2026-03-23
00612479124417McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124424McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124431McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160385McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160392McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160408McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
10194484321588N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
10194484321595N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
10194484321533N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321564N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321571N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321267N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321274N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321304N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321311N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321328N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321335N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321342N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20849832023214Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024174Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024310Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024327Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024358Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832025331Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23