DeRoyal

Primary DI
50749756595938
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
77-400507
Device description
SELDINGER NEEDLE 18GX4 25C TWO PART
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756595938PackageGS125In Commercial Distribution
00749756595933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975659593850749756595938
00749756595933007497565959337497565959330749756595933

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. 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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
10841156105921VSITELEFLEX INCORPORATEDDRE2020-02-06
10841156105945VSITELEFLEX INCORPORATEDDRE2020-02-06
10841156105907VSITELEFLEX INCORPORATEDDRE2020-01-27
10841156105914VSITELEFLEX INCORPORATEDDRE2020-01-27
10841156105938VSITELEFLEX INCORPORATEDDRE2020-01-27
10841156105952VSITELEFLEX INCORPORATEDDRE2020-01-27
08714729295822NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729295839NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729295853NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729375555NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729742913NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
10827002237374EvolutionCook Vandergrift Inc.DRE2016-09-24
10827002237466EvolutionCook Vandergrift Inc.DRE2016-09-24
10827002237473EvolutionCook Vandergrift Inc.DRE2016-09-24
10827002465395EvolutionCook Vandergrift Inc.DRE2016-09-24
10827002465401EvolutionCook Vandergrift Inc.DRE2016-09-24
10827002465418EvolutionCook Vandergrift Inc.DRE2016-09-24
10884450007829Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450007867Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450007904Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450008086Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450008109Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450008147Prelude®Merit Medical Systems, Inc.DRE2016-09-24