FDA.reportPublic FDA data

Centurion

Primary DI
10653160351283
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
I68925
Catalog number
I68925
Device description
HANK UTERINE DILATOR 11' 9/10FR 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
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
00653160351286PackageGS120In Commercial Distribution
10653160351283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160351286006531603512866531603512860653160351286
1065316035128310653160351283

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.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776427948MillenniumAvalign Technologies, Inc.HDQ2026-08-27
00190776423858MillenniumAvalign Technologies, Inc.HDQ2026-08-26
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
00198506093241ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-28
00198506093357ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-28
00860011927686Monarch Medical ProductsBioteque Taiwan Ltd.HDQ2026-07-24
04719894436517LTL MedicalBioteque Taiwan Ltd.HDQ2026-07-24
00198506093692ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093708ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093715ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506093722ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-22
00198506092466ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092473ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
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00198506092497ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092503ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092510ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092527ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092534ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092541ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092558ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00198506092565ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17