FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756037402
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
30-055
Catalog number
30-055
Device description
Neuro Sponges
Published
2021-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFQGAUZE/SPONGE, INTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756037403PackageGS120In Commercial Distribution
50749756037407PackageGS120In Commercial Distribution
00749756037402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975603740330749756037403
5074975603740750749756037407
00749756037402007497560374027497560374020749756037402

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical spongeA sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402699DeRoyal25-1104EU25-1104EU2026-07-22
00749756402705DeRoyal25-1104EUN25-1104EUN2026-07-22
00749756402750DeRoyal25-1401YEU25-1401YEU2026-07-22
00749756402767DeRoyal25-1403EU25-1403EU2026-07-22
00749756402781DeRoyal25-1702EU25-1702EU2026-07-22
00749756402798DeRoyal25-1702EUN25-1702EUN2026-07-22
00749756402910DeRoyal25-0403EUN25-0403EUN2026-07-22
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253047509CurityCardinal Health 200, LLCEFQ2026-04-08
50192253067888ASOCardinal Health 200, LLCEFQ2026-01-20
B960RED202RED Prep-KitNeuraxis, Inc.EFQ2025-01-09
00630094194110Bioseal Inc.BIOSEALEFQ2023-10-11
10192253047523CurityCardinal Health 200, LLCEFQ2023-10-09
10192253047561CurityCardinal Health 200, LLCEFQ2023-10-09
00665973017228DukalDukal LLCEFQ2022-12-06
00665973017235DukalDukal LLCEFQ2022-12-06
00665973017242DukalDukal LLCEFQ2022-12-06
00683534830017A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830024A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830031A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830048A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830055A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830062A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830079A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830086A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830093A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830109A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830116A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830123A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830130A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830147A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830154A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830161A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830178A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830185A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830277A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830284A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830307A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19