FDA.reportPublic FDA data

ViaMed

Primary DI
00811382011122
Brand
ViaMed
Company
RECE INTERNATIONAL CORPORATION
Model
15111
Device description
Speculum M
Published
2017-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050887000GONGDONG DISPOSABLE VAGINAL SPECULUMZhejiang Gongdong Medical Plastic Factory2005-07-11HIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811382011122PrimaryGS10
00811382016097Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811382011122008113820111228113820111220811382011122
00811382016097008113820160978113820160970811382016097

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

Regulatory Flags#

DUNS number
787828537
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811382011467ViaMed13410-MIX2020-11-27
00811382011498ViaMed13411-BLUE2020-12-04
00811382011504ViaMed13410-BLUE2020-12-04
00811382013119ViaMed17001-R2019-05-20
00811382013447ViaMed17310-R2017-09-20
00811382013454ViaMed17311-R2017-09-20
00811382013461ViaMed17312-R2017-09-20
00811382018756ViaMed17317-R2017-09-20
00811382018770ViaMed17318-R2017-09-20
00811382019623ViaMed17310-Y2017-09-20
00811382019630ViaMed17311-Y2017-09-20
00811382019647ViaMed17312-Y2017-09-20
00811382019654ViaMed17317-Y2017-09-20
00811382019661ViaMed17318-Y2017-09-20
00811382015601ViaMed131102021-10-15
00811382011726ViaMed131102021-10-15
00811382011481ViaMed13411-BLUE2020-12-04
00811382011542ViaMed13410-BLUE2020-12-04
00811382010774ViaMed13312-BLUE2020-11-27
00811382010804ViaMed13450-BLACK2020-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10860008900323ClearSpecClearspec LLCHIB2025-10-29
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
00199536930049BluelineTransparent Supply Solutions Ltd.HIB2025-09-22
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
06972903330031SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11
06972903331113SHENGBOYUHUAN CITY SHENGBO MOULD MANUFACTURING CO.,LTD.HIB2025-05-11