FDA.reportPublic FDA data

Centurion

Primary DI
00653160335774
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
PE3625
Catalog number
PE3625
Device description
IUD REMOVAL
Published
2019-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00653160335774PackageGS125In Commercial Distribution
10653160335771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160335774006531603357746531603357740653160335774
1065316033577110653160335771

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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
00653160294248CenturionMNS101552016-11-11
00653160315974CenturionCIT66352018-04-09
00653160284218CenturionCIT59202017-03-03
00653160274882CenturionPE31802018-02-11
00653160389753CenturionDM485BDM485B2025-09-17
00653160389296CenturionBT235BBT235B2025-08-24
00653160389319CenturionCSS640ACSS640A2025-08-24
00653160389494CenturionDT23104DT231042025-08-24
00653160388992CenturionSUT14785ASUT14785A2025-08-18
00653160389357CenturionDT23103DT231032025-08-18
00653160389067CenturionDYNDV2722DYNDV27222025-08-09
00653160389074CenturionSUT19525ASUT19525A2025-08-09
00653160389159CenturionIVS1090BIVS1090B2025-08-09
00653160388978CenturionMNS10875BMNS10875B2025-08-02
00653160386936CenturionIVS4222IVS42222025-07-21
00653160388909CenturionSUT21465BSUT21465B2025-07-21
00653160388848CenturionDYNDC3166DDYNDC3166D2025-07-18
00653160388732CenturionSUT19955BSUT19955B2025-07-14
00653160388770CenturionDM875ADM875A2025-07-14
00653160388794CenturionSUT12485ASUT12485A2025-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50198956273533CARDINAL HEALTHCardinal Health 200, LLCMLT2025-12-11
00653160388985MEDLINEMEDLINE INDUSTRIES, INC.MLT2025-08-02
40198459445218MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-28
40198459383749MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
40198459389208MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-07-02
40198459363727MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-09
40198459351748MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MLT2025-06-02
50198956037647CARDINAL HEALTHCardinal Health 200, LLCMLT2025-05-21
40198459323714Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
40198459325138Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
40198459326227Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-18
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40198459315818Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-04-07
50198956019087CARDINAL HEALTHCardinal Health 200, LLCMLT2025-04-03
50197106946365CARDINAL HEALTHCardinal Health 200, LLCMLT2025-03-17
40198459273552Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-03-02
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50197106952083CARDINAL HEALTHCardinal Health 200, LLCMLT2025-02-17
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40198459257026Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2025-02-09
50197106921027CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-28
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50197106899838CARDINAL HEALTHCardinal Health 200, LLCMLT2025-01-09
40198459222048Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
40198459225568Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-29
40198459200763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-12-01
40198459192464Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-24
40198459173227Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MLT2024-11-17