FDA.reportPublic FDA data

Centurion

Primary DI
00653160014488
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
PE280
Published
2016-11-11
Public version status
Update
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
MLTPelvic exam kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLTPelvic Exam KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50653160014483PackageGS125In Commercial Distribution
00653160014488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5065316001448350653160014483
00653160014488006531600144886531600144880653160014488

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic examination kitA collection of sterile devices designed to perform a pelvic examination. It contains all of the various instruments, specimen collection materials, and pharmaceuticals necessary for this procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)248-4058CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
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
10653160393757CENTURIONCIT5215ACIT5215A2026-05-27
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956327320CARDINAL HEALTHCardinal Health 200, LLCMLT2026-03-09
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10198459445217MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-28
10198459383748MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
10198459389207MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
10198459363726MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-09
10198459351747MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-02
10198956037649CARDINAL HEALTHCardinal Health 200, LLCMLT2025-05-21
10198459323713Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459325137Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459326226Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
10198459315817Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-07
10198956019089CARDINAL HEALTHCardinal Health 200, LLCMLT2025-04-03
10197106946367CARDINAL HEALTHCardinal Health 200, LLCMLT2025-03-17
10198459273551Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-03-02
10198459268724Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-23
10197106952085CARDINAL HEALTHCardinal Health 200, LLCMLT2025-02-17
10198459257025Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-09
10197106921029CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-28
10197106641224CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
10197106899830CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
10198459222047Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
10198459225567Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
10198459218002Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-22
10198459219467Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-22
10198459200762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-01
10198459192463Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-24
10198459173226Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-17