FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756034765
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
31-838
Catalog number
31-838
Device description
Glass Slide
Published
2021-06-30
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
50749756034765PackageGS150In Commercial Distribution
00749756034760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975603476550749756034765
00749756034760007497560347607497560347600749756034760

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
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20810050855833Microscope SlidesTYPENEX MEDICAL LLCKEW2026-03-23
00612479124448McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124455McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124462McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160651McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160668McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160675McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
09551020410092PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410320PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410337PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410344PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410351PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410368PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
20194484321585N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
20194484321592N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
20194484321530N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321561N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321578N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321264N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321271N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321301N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321318N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321325N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321332N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321349N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
00849832023210Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024170Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024316Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024323Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024354Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23