FDA.reportPublic FDA data

ClearSpec

Primary DI
00860008900357
Brand
ClearSpec
Company
Clearspec LLC
Model
104NS
Catalog number
104NS
Device description
ClearSpec Single Use Vaginal Speculum (Large) without sheath
Published
2025-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K130046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130046000CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLC2013-08-06HIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008900357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008900357008600089003578600089003570860008900357

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
075061406
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860008900309ClearSpec1021022025-10-29
10860008900316ClearSpec1031032025-10-29
10860008900323ClearSpec1041042025-10-29
10860008900330ClearSpec102NS102NS2025-10-29
10860008900347ClearSpec103NS103NS2025-10-29
10860008900354ClearSpec104NS104NS2025-10-29
10860008900361ClearSpec1051052025-10-29
20860008900368ClearSpec1051052025-10-29
00860008900302ClearSpec1021022025-10-29
00860008900319ClearSpec1031032025-10-29
00860008900326ClearSpec1041042025-10-29
00860008900333ClearSpec102NS102NS2025-10-29
00860008900340ClearSpec103NS103NS2025-10-29
00860008900364ClearSpec1051052025-10-29

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
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