FDA.reportPublic FDA data

Centurion

Primary DI
10653160307556
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
VS200LED
Published
2017-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIBSpeculum, vaginal, nonmetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160307559PackageGS125In Commercial Distribution
10653160307556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160307559006531603075596531603075590653160307559
1065316030755610653160307556

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, single-useA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.

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
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
10653160251729CENTURIONMNS7810MNS78102022-01-01
10653160254799CENTURIONCHT890CHT8902022-01-01
10653160257028CENTURIONSUT18270SUT182702022-01-02
10653160257417CENTURIONCIT5460CIT54602016-09-05
10653160279068CENTURIONSUT19360SUT193602022-01-02
10653160291060CENTURIONMNS9970MNS99702022-01-02
10653160292029CENTURIONMNS9715MNS97152022-01-02
10653160292562CENTURIONMNS9820MNS98202022-01-02
10653160293798CENTURIONIV8310EIV8310E2017-08-18
10653160310006CENTURIONID2060ID20602021-11-29
10653160313243CENTURIONSUT20670SUT206702022-01-02
10653160313823CENTURIONSUT20685SUT206852022-01-02
10653160316626CENTURIONMNS11230MNS112302018-05-03
10653160317210CENTURIONTC7955TC79552022-01-02
10653160318170CENTURIONOR2050OR20502022-01-02
10653160318361CENTURIONMNS11280MNS112802022-01-01
10653160319160CENTURIONIV8675IV86752018-07-16
10653160323211CENTURIONMNS11745MNS117452022-01-01
10653160324065CENTURIONMNS11760MNS117602022-01-01
10653160325000CENTURIONCIT6905CIT69052022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015815705Rosa SpeculumMY VILLAGE INNOVATIONS INC.HIB2026-07-20
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00860000270496Nella Comfort Kit First Time ExamCEEK WOMEN'S HEALTHHIB2026-05-05
00860000270472Nella Comfort Kit Classic RetailCEEK WOMEN'S HEALTHHIB2026-04-15
00860000270489Nella Comfort Kit Curves RetailCEEK WOMEN'S HEALTHHIB2026-04-15
10860008900309ClearSpecClearspec LLCHIB2025-10-29
10860008900316ClearSpecClearspec LLCHIB2025-10-29
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10860008900330ClearSpecClearspec LLCHIB2025-10-29
10860008900347ClearSpecClearspec LLCHIB2025-10-29
10860008900354ClearSpecClearspec LLCHIB2025-10-29
00860008900302ClearSpecClearspec LLCHIB2025-10-29
00860008900319ClearSpecClearspec LLCHIB2025-10-29
00860008900326ClearSpecClearspec LLCHIB2025-10-29
00860008900333ClearSpecClearspec LLCHIB2025-10-29
00860008900340ClearSpecClearspec LLCHIB2025-10-29
00860008900357ClearSpecClearspec LLCHIB2025-10-29
00199536930001BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930018BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930025BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
00199536930032BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
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00199536930056BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
05010058091450UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091474UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091498UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091535UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091573UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-06-18
05010058091429UltraspecROBINSON HEALTHCARE LIMITEDHIB2025-05-21
06972903330024SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11