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
10653160394068CENTURIONSUT11035ASUT11035A2026-07-21
10653160239369CENTURIONCHT805CHT8052022-01-01
10653160243694CENTURIONSUT17770SUT177702022-01-02
10653160277859CENTURIONSUT19145SUT191452022-01-02
10653160283966CENTURIONCVI4145CVI41452017-08-14
10653160285267CENTURIONMNS9625MNS96252022-01-02
10653160317937CENTURIONTRI66800TRI668002022-01-02
10653160322948CENTURIONSUT20915SUT209152022-01-02
10653160330783CENTURIONSUT21230ASUT21230A2022-01-02
10653160333883CENTURIONSUT18765ASUT18765A2022-01-02
10653160345220CENTURIONMNS13075MNS130752022-01-01
10653160360247CENTURIONMNS7285AMNS7285A2023-05-22
10653160374183CENTURIONMNS11780BMNS11780B2024-05-02
00653160013641CENTURIONMNS1080MNS10802022-01-01
00653160017762CENTURIONUVT235UVT2352022-01-02
00653160191349CENTURIONMNS5555MNS55552022-01-01
00653160199352CENTURIONSUT1243ASUT1243A2022-01-02
00653160200867CENTURIONSUT15260SUT152602022-01-02
00653160228397CENTURIONSUT17155SUT171552022-01-02
00653160130683Centurion589784ST589784ST2022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00198506092480ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
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
00198506092572ELMED INCORPORATEDELMED INCORPORATEDHDQ2026-07-17
00348783011265Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011272Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011289Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011296Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011302Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
00348783011319Premier DilatorPREMIER DENTAL PRODUCTS COMPANYHDQ2026-06-08
04719894432434BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
04719894432441BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
04719894432458BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
G586NSGU40600160Novo SurgicalNOVO SURGICAL, INC.HDQ2024-03-08
GYNX42111GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42121GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42131GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42211GynexGYNEX CORPORATIONHDQ2023-12-19