FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756364015
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-10533
Catalog number
89-10533
Device description
DR. CHOATE E-PACK
Published
2021-07-12
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
KDDKit, surgical instrument, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756364015PackageGS19In Commercial Distribution
00749756364010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975636401550749756364015
00749756364010007497563640107497563640100749756364010

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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
true
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
M7403150031OptiMesh Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.KDD2026-03-20
00850074437048OftalOnePack, Oftal-OneOFTAL-ONE INC.KDD2026-02-26
00850074437109OftalOnePack, Oftal-OneOFTAL-ONE INC.KDD2026-02-26
00850074437116OftalOnePack, Oftal-OneOFTAL-ONE INC.KDD2026-02-26
50885380211193Aero-MedAERO-MED, LLCKDD2026-02-13
10653160392248Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2026-02-11
07901125600584Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600591Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600607Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600614Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
50749756397808DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-01-22
10653160391302MedlineMEDLINE INDUSTRIES, INC.KDD2026-01-15
50885380206656Aero-MedAERO-MED, LLCKDD2026-01-15
00887868572524ToggleLoc™ WasherLoc™Biomet Orthopedics, LLCKDD2026-01-14
00850074437123OftalOnePackOFTAL-ONE INC.KDD2026-01-05
10653160390671Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2025-12-04
08800071700517TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
40198459450649MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459453510MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459454647MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459455231MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459456238MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459697MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459765MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459888MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459460044MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459471767MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459473846MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459474669MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459476106MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18