FDA.reportPublic FDA data

Centurion

Primary DI
00653160351279
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
I68915
Catalog number
I68915
Device description
HANK UTERINE DILATOR 11' 5/6FR STERILE
Published
2022-03-28
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
HDQDILATOR, CERVICAL, FIXED SIZE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160351279PackageGS120In Commercial Distribution
10653160351276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160351279006531603512796531603512790653160351279
1065316035127610653160351276

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-diameter cervical dilator, single-useA rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
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
10653160277361CenturionECT18234SCST2017-06-30
10653160309505CenturionART5052017-05-04
10653160319863CenturionSTCVC172018-08-17
10653160319870CenturionSTCVC182018-08-17
10653160319917CenturionSTCVC192018-08-17
10653160319924CenturionSTCVC202018-08-17
10653160319931CenturionSTCVC212018-08-17
10653160319948CenturionCVI3535A2018-08-17
10653160319986CenturionSTCVC222018-08-18
10653160321194CenturionCVI45102018-10-04
10653160324591CenturionART8852019-02-10
10653160326557CenturionART9052019-05-05
10653160327738CenturionGW1850IGW1850I2020-05-18
10653160330868CenturionECVC7165ECVC71652019-10-31
10653160330974CenturionCVI4650CVI46502019-11-04
10653160338239Medline Industries, Inc.STCVC18STCVC182020-01-02
10653160338253Medline Industries, Inc.STCVC17STCVC172020-01-02
10653160339038Medline Industries, Inc.STCVC22STCVC222020-01-22
10653160339052Medline Industries, Inc.STCVC21STCVC212020-01-22
10653160339083Medline Industries, Inc.STCVC20STCVC202020-01-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776419141MillenniumAvalign Technologies, Inc.HDQ2026-08-23
00190776419608MillenniumAvalign Technologies, Inc.HDQ2026-08-23
00190776419615MillenniumAvalign Technologies, Inc.HDQ2026-08-23
00190776407469MillenniumAvalign Technologies, Inc.HDQ2026-07-31
00198506093180ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-28
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00860011927686Monarch Medical ProductsBioteque Taiwan Ltd.HDQ2026-07-24
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00198506093692ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
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00198506092541ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092558ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092565ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17