FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756838530
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
HD-395-2500REDEU
Catalog number
HD-395-2500REDEU
Device description
SPONGE BOWL - RED
Published
2021-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNYBASIN, EMESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756838530PackageGS1160In Commercial Distribution
00749756838535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975683853050749756838530
00749756838535007497568385357497568385350749756838535

GMDN Terms#

Term, Definition table
TermDefinition
Sponge bowl, single-useA sterile receptacle specifically designed to store and/or collect sponges. It is typically made of plastic or metallic [e.g., aluminium (Al)] foil, is frequently changed, and has single-patient application; it may be prepacked containing the sponges. 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
50198956251357CARDINAL HEALTHCardinal Health 200, LLCFNY2025-12-10
00840216128262ASP GLOBALAsp Global, LLCFNY2025-11-20
00840216128286ASP GLOBALAsp Global, LLCFNY2025-11-20
50198956137712CARDINAL HEALTHCardinal Health 200, LLCFNY2025-08-28
00194613019600MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
00194613019914MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
00194613052256MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
00194613116972MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
06931918189195AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
06931918190085AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
06931918129313AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
06931918140820AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
06931918145467AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
26931918146840Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
06931918157088AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
00840216128279ASP GLOBALAsp Global, LLCFNY2025-06-17
00840216128293ASP GLOBALAsp Global, LLCFNY2025-06-17
00810180842228DispoSafety Biohazard Bags, 39" x 33", 2 MIL, 33 GallonDynarex CorporationFNY2025-06-16
00810180842235DispoSafety Biohazard Bags, 40" x 46", 2 MIL, 45 GallonDynarex CorporationFNY2025-06-16
00810180842242DispoSafety Biohazard Bags, 40" x 46", 3 MIL, 45 GallonDynarex CorporationFNY2025-06-16
00810180842259DispoSafety Biohazard Bags, 36" x 58", 2 MIL, 45 GallonDynarex CorporationFNY2025-06-16
10661392008080LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
10661392025490LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
10661392045337LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
10661392027661LSL HEALTHCARELSL Industries, LLCFNY2025-05-15
10661392004624LSL HEALTHCARELSL Industries, LLCFNY2025-04-22
00810180841702DispoSafety Medical Waste Biohazard Bags, 24" x 25.6", 1.18 MIL, 12 GallonDynarex CorporationFNY2025-04-07
00810180841719DispoSafety Medical Waste Biohazard Bags, 36" x 30", 1.2 MIL, 30 GallonDynarex CorporationFNY2025-04-07
00810180841696DispoSafety Medical Waste, Biohazard Bags with Ties,12 Gal,24" x 25.6",0.78 MIL Dynarex CorporationFNY2025-04-07
50198956044898CARDINAL HEALTHCardinal Health 200, LLCFNY2025-04-03