FDA.reportPublic FDA data

DeRoyal

Primary DI
30749756554221
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
30-810
Catalog number
30-810
Device description
Instrument Organizer
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
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756554221PackageGS110In Commercial Distribution
50749756554225PackageGS140In Commercial Distribution
00749756554220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975655422130749756554221
5074975655422550749756554225
00749756554220007497565542207497565542200749756554220

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, single-use, sterileA sterile device intended to be used in the operating room (OR) by staff to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. 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
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
00887482138373SterionASPEN SURGICAL PRODUCTS, INC.KDC2026-02-15
10653160391098Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDC2025-12-19
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00194613020576MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613043209MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613044381MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613044633MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045296MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045302MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045531MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613047153MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
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00194613054441MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054472MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054496MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054571MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613054762MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
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00194613088118MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088132MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613088194MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089672MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089757MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613089764MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613090890MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613091330MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613091774MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613093228MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01