FDA.report

DeRoyal

Primary DI
30749756024199
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
26-012
Device description
Light Handle Cover ,2 per pack
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FTALight, surgical, accessories

Product Code Classifications

CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30749756024199PackageGS130In Commercial Distribution
50749756024193PackageGS160In Commercial Distribution
00749756024198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975602419930749756024199
5074975602419350749756024193
00749756024198007497560241987497560241980749756024198

GMDN Terms

TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Sterilization Methods

Method

Contacts

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 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 DIBrandCompanyProduct codePublished
00748426144563Medline-MicrotekMicrotek Medical LLCFTA2026-02-18
10748426142931Skytron®Microtek Medical LLCFTA2026-02-05
10748426145024NAMicrotek Medical LLCFTA2026-02-05
00748426262700Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
00724995245054HexaVueBLACK DIAMOND VIDEO, INC.FTA2025-10-17
00810008184943OlympusGyrus ACMI, LLCFTA2025-09-19
00810008185018OlympusGyrus ACMI, LLCFTA2025-09-19
00810008185032OlympusGyrus ACMI, LLCFTA2025-09-19
00810008185063OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047150OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047242OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047259OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047266OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047273OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047280OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047297OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047303OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047310OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047327OlympusGyrus ACMI, LLCFTA2025-09-19
00821925047365Gyrus ACMIGyrus ACMI, LLCFTA2025-09-19
05060792970658LITEXLitex Manufacturing, Inc.FTA2025-08-02
05060792971242LITEXLitex Manufacturing, Inc.FTA2025-08-02
05060792971662LITEXLitex Manufacturing, Inc.FTA2025-08-02
00560792971716LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970009LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970016LitexLitex Manufacturing, Inc.FTA2025-08-01
05060792970023LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970030LITEXLitex Manufacturing, Inc.FTA2025-08-01
05060792970047LitexLitex Manufacturing, Inc.FTA2025-08-01
05060792970054LITEXLitex Manufacturing, Inc.FTA2025-08-01