FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756905867
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
SM45SCNS
Device description
Safety Scalpel
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDZHANDLE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756905867PackageGS1500In Commercial Distribution
00749756905862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975690586750749756905867
00749756905862007497569058627497569058620749756905862

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. 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
false
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
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267742Snowden-PencerSTERIS Deutschland GmbHGDZ2026-09-25
D955BLAHST1Paul BandittTerlain Enterprises, Inc.GDZ2026-09-25
00724995267728Snowden-PencerSTERIS Deutschland GmbHGDZ2026-09-24
00190776429072MillenniumAvalign Technologies, Inc.GDZ2026-09-04
00724995314682V. MuellerSteris CorporationGDZ2026-08-21
00724995314699V. MuellerSteris CorporationGDZ2026-08-21
00724995314705V. MuellerSteris CorporationGDZ2026-08-21
00724995314712V. MuellerSteris CorporationGDZ2026-08-21
00724995314729V. MuellerSteris CorporationGDZ2026-08-21
00724995317362V. MuellerSteris CorporationGDZ2026-08-21
00724995317379V. MuellerSteris CorporationGDZ2026-08-21
00724995320492V. MuellerSteris CorporationGDZ2026-08-21
00724995320508V. MuellerSteris CorporationGDZ2026-08-21
00724995320515V. MuellerSteris CorporationGDZ2026-08-21
00724995320522V. MuellerSteris CorporationGDZ2026-08-21
00724995320539V. MuellerSteris CorporationGDZ2026-08-21
00724995343446V. MuellerSteris CorporationGDZ2026-08-21
04054462913466evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913473evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913480evonosevonos GmbH & Co. KGGDZ2026-08-19
04054462913527evonosevonos GmbH & Co. KGGDZ2026-08-19
00190776422837MillenniumAvalign Technologies, Inc.GDZ2026-08-03
07613327651188VersiQuadSTRYKER CORPORATIONGDZ2026-07-22
00190776396800MillenniumAvalign Technologies, Inc.GDZ2026-07-14
00850083275563Intrace USAPILOTIS TECH LLCGDZ2026-07-03
00810055255689Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255696Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255702Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255726Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255788Surgical DesignSurgical Design, Inc.GDZ2026-06-26