FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756600533
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
88-1567
Device description
Electrode, Lletz
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGIELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756600533PackageGS110In Commercial Distribution
00749756600538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975660053350749756600533
00749756600538007497566005387497566005380749756600538

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.

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
false
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
00887482177044BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177082BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482141656BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177075BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177570BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177594BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177723BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177754BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177792BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177839BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177877BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177914BovieSYMMETRY SURGICAL INC.HGI2024-08-27
10887482177928BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177952BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177976BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177990BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178010BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178034BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178058BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178072BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178133BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178171BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178218BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178232BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178256BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178270BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178294BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178317BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178331BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178355BovieSYMMETRY SURGICAL INC.HGI2024-08-27