FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756561501
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
47-513
Device description
ST SUTURE REMOVAL KIT
Published
2017-04-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCZSuture removal kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCZSuture Removal KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756561506PackageGS150In Commercial Distribution
00749756561501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975656150650749756561506
00749756561501007497565615017497565615010749756561501

GMDN Terms#

Term, Definition table
TermDefinition
Suture removal kitA collection of various sterile instruments, dressings, and pharmaceuticals designed to remove sutures from a patient. It typically includes a disinfectant, scissors, forceps, gauze and bandages. 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
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
10198956404304CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-04-15
10704411018834AMSure ® SUTURE REMOVAL KITAMSINO INTERNATIONAL, INC.MCZ2026-04-03
10704411018841AMSure ® Suture Removal KitAMSINO INTERNATIONAL, INC.MCZ2026-04-03
10704411018858AMSure ® Suture Removal KitAMSINO INTERNATIONAL, INC.MCZ2026-04-03
10198956291362CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-03-26
10198956326873CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-03-16
10198956228993CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-02-09
10198956254770CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-12-02
10198956241046CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-11-19
10198956260030CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-11-13
10198956160439CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-08-28
10198956112483CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-07-09
10198956057920CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-06-05
10198956053960CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-05-16
10198459280498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10198459280566Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10198459280573Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10198459281778Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10197106916186CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-02-17
10197106818459CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-12-13
10197106828960CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-11-22
10198459182730Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-11-17
10197106833131CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-11-13
10198459137402Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-11-03
10198459120886Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-10-20
10198459145063Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-10-13
10198459137396Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-10-06
10197106752173CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-09-17
10198459090202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-09-08
10198459092350Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-09-08