FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756037872
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
30-068
Catalog number
30-068
Device description
Neuro Sponges
Published
2021-08-23
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
30749756037878PackageGS120In Commercial Distribution
50749756037872PackageGS120In Commercial Distribution
00749756037877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975603787830749756037878
5074975603787250749756037872
00749756037877007497560378777497560378770749756037877

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
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
10192253067880ASOCardinal Health 200, LLCEFQ2026-01-20
00766588235745628 - Non-Stick Pads 2"x 3" - 4/unitCertified Safety Manufacturing, Inc.EFQ2025-12-17
30192253045905CurityCardinal Health 200, LLCEFQ2024-11-12
50192253045916CurityCardinal Health 200, LLCEFQ2024-09-10
10630094194117Bioseal Inc.BIOSEALEFQ2023-10-11
50192253047521CurityCardinal Health 200, LLCEFQ2023-10-09
50192253047569CurityCardinal Health 200, LLCEFQ2023-10-09
50732224004254Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004261Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004278Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004285Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004292Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004308Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004247All-Gauze Sponges PremiumCROSSTEX INTERNATIONAL, INC.EFQ2023-06-22
00766588110110637 - Certi-Gauze Pads - 3"x 3" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110141638 - Certi-Gauze Compress - 18"x 36" - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110172639 - Certi-Gauze Compress - 36"x 36" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110219640 - Certi-Gauze Compress - 24"x 72" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110301628 - Certi-Non-Stick Pads - 2"x 3" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588310039Certi-Non Stick Pads - 2"x 3" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312057Certi-Gauze Pads - 3"x 3" - 100/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312095Certi-Gauze Pads - 2"x 2" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312101Certi-Gauze Pads - 3"x 3" - 10/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312118Certi-Gauze Pads - 3"x 3" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312132Certi-Gauze Pads - 4"x 4" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110028622 - Certi-Gauze Bandage Compress - 2" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110059623 - Certi-Gauze Bandage Compress - 3" - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110080624 - Certi-Gauze Bandage Compress - 4" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110240634 - Certi-Gauze Roll - 2" x 6 yards - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110271635 - Certi-Gauze Roll - 4" x 6 yards - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27