FDA.reportPublic FDA data

MedPride

Primary DI
10352410462457
Brand
MedPride
Company
SHIELD-LINE, LLC
Model
46245
Catalog number
MPR-46245
Device description
Vaginal Speculum Disposable - Lg - 10/10/cs
Published
2019-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10352410462457PrimaryGS10
00352410462450Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035241046245710352410462457
00352410462450003524104624503524104624500352410462450

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.

Regulatory Flags#

DUNS number
078518916
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10352410653640MedPrideSilicone TapeMPR-653642022-09-15
10352410516129MedPrideSIZE 6.0MPR-516122021-10-07
10352410516136MedPrideSIZE 6.5MPR-516132021-10-07
10352410516143MedPrideSIZE 7.0MPR-516142021-10-07
10352410516150MedPrideSIZE 7.5MPR-516152021-10-07
10352410516167MedPrideSIZE 8.0MPR-516162021-10-07
10352410516174MedPrideSIZE 8.5MPR-516172021-10-07
00352410516122MedPrideSIZE 6.0MPR-516122021-10-07
00352410516139MedPrideSIZE 6.5MPR-516132021-10-07
00352410516146MedPrideSIZE 7.0MPR-516142021-10-07
00352410516153MedPrideSIZE 7.5MPR-516152021-10-07
00352410516160MedPrideSIZE 8.0MPR-516162021-10-07
00352410516177MedPrideSIZE 8.5MPR-516172021-10-07
10352410652728MedPride65272652722019-08-07
10352410652742MedPride65274MPR-652742019-08-07
10352410652780MedPride65278MPR-652782019-08-07
10352410702874MedPride Reinforced Surgical Gowns 70287702872020-07-08
10352410702843MedPride Reinforced Surgical Gowns 70284702842018-08-30
10352410702850MedPride Reinforced Surgical Gowns 70285702852018-08-31
10352410702867MedPride Reinforced Surgical Gowns 70286702862018-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860000270472Nella Comfort Kit Classic RetailCEEK WOMEN'S HEALTHHIB2026-04-15
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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