FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756256568
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
D6904
Catalog number
D6904
Device description
ST. Stainless Steel Handle
Published
2021-07-09
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
GDXSCALPEL, ONE-PIECE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756256569PackageGS110In Commercial Distribution
50749756256563PackageGS140In Commercial Distribution
00749756256568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975625656930749756256569
5074975625656350749756256563
00749756256568007497562565687497562565680749756256568

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable 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
Lot or batch
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
00810111227353ScalpelTreace Medical Concepts, Inc.GDX2026-06-05
00810111227346Scalpel Treace Medical Concepts, Inc.GDX2026-05-19
00850069257002LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257019LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257026LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257040LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257057LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257064LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257071LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257088LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257095LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257101LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257118LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257033LumohsNANO SURGICAL, INCGDX2026-02-20
16945630141826STERiLANCESterilance Medical (Suzhou) Inc.GDX2026-02-05
00818788021892Epimed International, Inc.EPIMED INTERNATIONAL, INCGDX2025-11-21
16945630137584index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137591index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137607index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137614index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139069index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139076index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
10198459343490MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GDX2025-05-22
16945630114080BardSterilance Medical (Suzhou) Inc.GDX2025-02-28
10197344025190MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025206MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025213MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
08902895129212KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129229KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129236KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09