FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756678414
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
D6054
Catalog number
D6054
Device description
SF4 Fine Reusable Scalpel Handle
Published
2021-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GESBLADE, SCALPEL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756678415PackageGS110In Commercial Distribution
50749756678419PackageGS110In Commercial Distribution
00749756678414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975667841530749756678415
5074975667841950749756678419
00749756678414007497566784147497566784140749756678414

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, reusableA 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 device is typically made of high-grade stainless steel alloy. 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
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
00810055255184Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255191Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255207Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255214Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255238Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255245Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255252Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255269Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255276Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255283Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255290Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255313Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255320Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255337Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255368Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255382Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255429Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255436Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255443Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255450Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255467Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255474Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255511Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255528Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255535Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255542Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255559Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255566Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255580Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255597Surgical DesignSurgical Design, Inc.GES2026-09-26