FDA.reportPublic FDA data

Centurion

Primary DI
10653160349488
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
ED5013ST
Catalog number
ED5013ST
Device description
STERILE DILATOR, 10.5FR X 10.16CM
Published
2021-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFDCatheter introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFDCatheter Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160349481PackageGS150In Commercial Distribution
10653160349488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160349481006531603494816531603494810653160349481
1065316034948810653160349488

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.

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
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
10653160251729CENTURIONMNS7810MNS78102022-01-01
10653160254799CENTURIONCHT890CHT8902022-01-01
10653160257028CENTURIONSUT18270SUT182702022-01-02
10653160257417CENTURIONCIT5460CIT54602016-09-05
10653160279068CENTURIONSUT19360SUT193602022-01-02
10653160291060CENTURIONMNS9970MNS99702022-01-02
10653160292029CENTURIONMNS9715MNS97152022-01-02
10653160292562CENTURIONMNS9820MNS98202022-01-02
10653160293798CENTURIONIV8310EIV8310E2017-08-18
10653160310006CENTURIONID2060ID20602021-11-29
10653160313243CENTURIONSUT20670SUT206702022-01-02
10653160313823CENTURIONSUT20685SUT206852022-01-02
10653160316626CENTURIONMNS11230MNS112302018-05-03
10653160317210CENTURIONTC7955TC79552022-01-02
10653160318170CENTURIONOR2050OR20502022-01-02
10653160318361CENTURIONMNS11280MNS112802022-01-01
10653160319160CENTURIONIV8675IV86752018-07-16
10653160323211CENTURIONMNS11745MNS117452022-01-01
10653160324065CENTURIONMNS11760MNS117602022-01-01
10653160325000CENTURIONCIT6905CIT69052022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160386315MEDLINEMEDLINE INDUSTRIES, INC.OFD2025-02-14
10653160386278MEDLINEMEDLINE INDUSTRIES, INC.OFD2025-02-11
10653160386285MEDLINEMEDLINE INDUSTRIES, INC.OFD2025-02-11
10653160381983MEDLINEMEDLINE INDUSTRIES, INC.OFD2024-11-04
10653160381990MEDLINEMEDLINE INDUSTRIES, INC.OFD2024-11-04
10653160381808MEDLINEMEDLINE INDUSTRIES, INC.OFD2024-10-28
10653160366577MEDLINEMEDLINE INDUSTRIES, INC.OFD2023-09-28
10653160351825MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-04-04
10653160351924MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-04-04
10653160350705MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-02-21
10653160350729MEDLINEMEDLINE INDUSTRIES, INC.OFD2022-02-21
10653160349402MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-12-16
10653160348740MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-11-05
10653160348382MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-10-01
10193489111132MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18
10193489111149MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18
10193489111156MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18
10193489111163MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18
10193489111170MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-07-18
10653160347767CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOFD2021-07-13
10653160347422MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-06-02
10653160347026MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347033MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347040MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347101MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347149MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347163MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160347194MEDLINEMEDLINE INDUSTRIES, INC.OFD2021-05-23
10653160344551CenturionCENTURION MEDICAL PRODUCTS CORPORATIONOFD2020-09-02
10653160343806MEDLINEMEDLINE INDUSTRIES, INC.OFD2020-07-06