FDA.report

DeRoyal

Primary DI
50749756954841
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
DS1
Device description
AdapterDrager Sola Adapter
Published
2018-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FTALight, surgical, accessories

Product Code Classifications

CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756954841PackageGS11In Commercial Distribution
00749756954846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975695484150749756954841
00749756954846007497569548467497569548460749756954846

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
true
Expiration date on label
false
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