FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756776528
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
TM500D
Catalog number
TM500D
Device description
Laparoscopic Scope Warmer
Published
2021-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWVLaparoscopic accessories, gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756776528PackageGS110In Commercial Distribution
00749756776523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975677652850749756776528
00749756776523007497567765237497567765230749756776523

GMDN Terms#

Term, Definition table
TermDefinition
Instrument warmer, exothermic chemicalA sterile heating device intended to warm patient-contact instruments (e.g., rigid endoscopes or trocars) before they are introduced into body orifices or other parts of the body. It typically consists of an envelope that is wrapped around the instrument (e.g., laparoscope), and filled with a material which produces an exothermic chemical reaction when activated. 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
true
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
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00198506088520ELMED INCORPORATEDELMED INCORPORATEDNWV2026-02-23
00190776416072MillenniumAvalign Technologies, Inc.NWV2026-02-06
00190776415631MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415648MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415655MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415402MillenniumAvalign Technologies, Inc.NWV2026-01-27
00848657078108AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078115AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078122AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657077958AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657077965AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657078009AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00190776411275MillenniumAvalign Technologies, Inc.NWV2025-09-22
00860003326404AbGrabLapovations, LLCNWV2025-07-25
00190776402440MillenniumAvalign Technologies, Inc.NWV2025-06-23
00190776401733MillenniumAvalign Technologies, Inc.NWV2025-06-12
00190776396107MillenniumAvalign Technologies, Inc.NWV2025-05-09
00190776394936MillenniumAvalign Technologies, Inc.NWV2025-05-08
08904332600513MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDNWV2025-03-10
00198506045370ELMED INCORPORATEDELMED INCORPORATEDNWV2024-12-19
00198506073854ELMED INCORPORATEDELMED INCORPORATEDNWV2024-12-19
00190776389956MillenniumAvalign Technologies, Inc.NWV2024-11-18
00190776389109MillenniumAvalign Technologies, Inc.NWV2024-11-14
00198506017650ELMED INCORPORATEDELMED INCORPORATEDNWV2024-10-25
04547410515893FUJIFILMFUJIFILM CORPORATIONNWV2024-10-04
04547410524284FUJIFILMFUJIFILM CORPORATIONNWV2024-10-04