FDA.reportPublic FDA data

MedPride

Primary DI
10352410462440
Brand
MedPride
Company
SHIELD-LINE, LLC
Model
46244
Catalog number
46244
Device description
Vaginal Speculum Disposable - Md - 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
10352410462440PrimaryGS10
00352410462443Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035241046244010352410462440
00352410462443003524104624433524104624430352410462443

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
00199536930063BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930070BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930087BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930094BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930100BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930117BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00888937027389OfficeSPECCoopersurgical, Inc.HIB2026-08-06
00888937027396HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027402HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027419HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027426ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027433ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027440ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027457ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027464ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027327ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027334ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027341ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027358HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027365HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027372HER-SpecCoopersurgical, Inc.HIB2026-08-05
00860015815705Rosa SpeculumMY VILLAGE INNOVATIONS INC.HIB2026-07-20
20860000270421Nella Next Reusable Vaginal SpeculumCEEK WOMEN'S HEALTHHIB2026-06-25
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