FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756158916
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
25-300NS
Catalog number
25-300NS
Device description
Suture Bags
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756158911PackageGS1100In Commercial Distribution
00749756158916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975615891150749756158911
00749756158916007497561589167497561589160749756158916

GMDN Terms#

Term, Definition table
TermDefinition
Instrument management bagA flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. 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
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
00749756402699DeRoyal25-1104EU25-1104EU2026-07-22
00749756402705DeRoyal25-1104EUN25-1104EUN2026-07-22
00749756402750DeRoyal25-1401YEU25-1401YEU2026-07-22
00749756402767DeRoyal25-1403EU25-1403EU2026-07-22
00749756402781DeRoyal25-1702EU25-1702EU2026-07-22
00749756402798DeRoyal25-1702EUN25-1702EUN2026-07-22
00749756402910DeRoyal25-0403EUN25-0403EUN2026-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411534MillenniumAvalign Technologies, Inc.MDM2026-08-07
00190776423575MillenniumAvalign Technologies, Inc.MDM2026-08-07
00190776424435MillenniumAvalign Technologies, Inc.MDM2026-08-07
B382SD923286060Surgical DirectSurgical Direct, Inc.MDM2026-08-07
00190776422806MillenniumAvalign Technologies, Inc.MDM2026-08-03
00198506092350ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093197ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093586ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506090561ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092589ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092671ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092695ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092701ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092718ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092725ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093012ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093029ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093111ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093166ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093203ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093296ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093364ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093371ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093425ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093432ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093463ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092039ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092046ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092398ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092404ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27