FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756158879
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
26-003NS
Catalog number
26-003NS
Device description
Surgical Skin Markers
Published
2021-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
50749756158874PackageGS1100In Commercial Distribution
00749756158879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975615887450749756158874
00749756158879007497561588797497561588790749756158879

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking pen, single-useA dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.

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
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08
00749756402682DeRoyal25-0802EU25-0802EU2026-07-08
00749756402712DeRoyal25-1108EU25-1108EU2026-07-08
00749756402729DeRoyal25-1108EUN25-1108EUN2026-07-08
00749756402736DeRoyal25-1401EU25-1401EU2026-07-08
00749756402743DeRoyal25-1401EUN25-1401EUN2026-07-08
00749756402774DeRoyal25-1403EUN25-1403EUN2026-07-08
00749756402538DeRoyal25-0101EUN25-0101EUN2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20653405990328Infinity™Conmed CorporationKDD2026-06-10
10885380211195Aero-MedAERO-MED, LLCKDD2026-02-13
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10885380208515Aero-MedAERO-MED, LLCKDD2025-06-19
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10195327271626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327271770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273293Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273552Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327277680Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278243Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327279110Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10885380195365Aero-MedAERO-MED, LLCKDD2023-04-20
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
10885380194733Aero-MedAERO-MED, LLCKDD2023-02-24
10195327271633Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-12-18
10885380194108Aero-MedAERO-MED, LLCKDD2022-12-15
10195327242763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-11-23
10195327244835Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-11-23