FDA.report

DeRoyal

Primary DI
30749756964334
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
30-055-EG
Catalog number
30-055-EG
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
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EFQGAUZE/SPONGE, INTERNAL

Product Code Classifications

CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30749756964334PackageGS120In Commercial Distribution
50749756964338PackageGS120In Commercial Distribution
00749756964333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975696433430749756964334
5074975696433850749756964338
00749756964333007497569643337497569643330749756964333

GMDN Terms

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

Contacts

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

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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

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50732224004308Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
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