FDA.reportPublic FDA data

Centurion

Primary DI
00653160294125
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
GVS10MSTK
Catalog number
GVS10MSTK
Device description
ST. REPROCESSED GRAVES SPECULUM MEDIUM
Published
2022-01-01
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
HDFSPECULUM, VAGINAL, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160294125PackageGS125In Commercial Distribution
10653160294122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160294125006531602941256531602941250653160294125
1065316029412210653160294122

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.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
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02
10653160270775CenturionSV65NXTSV65NXT2022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10649111067235Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111067624Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111068966Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111069345Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111069574Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111069888Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
G586OB631721NCDT0Novo SurgicalNOVO SURGICAL, INC.HDF2024-02-22
G586OB631723NCDT0Novo SurgicalNOVO SURGICAL, INC.HDF2024-02-22
G586OB633804NC0Novo SurgicalNOVO SURGICAL, INC.HDF2024-02-22
10653160294153CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-02
10653160294122CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
10653160294948CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
10653160306528CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
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10381780495048Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-10-24
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10381780495147Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-10-24
10649111392276Sklar®SKLAR CORPORATIONHDF2018-09-24
10649111392283Sklar®SKLAR CORPORATIONHDF2018-09-24
10381780500490Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500506Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500513Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500520Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500537Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500544Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500551Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500582Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500599Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18