FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756054510
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-1293
Catalog number
32-1293
Device description
ST NEURO PATTY DISCS
Published
2021-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50749756054510PackageGS125In Commercial Distribution
00749756054515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975605451050749756054510
00749756054515007497560545157497560545150749756054515

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.

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
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

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