FDA.reportPublic FDA data

Prima Series® Vaginal Speculum

Primary DI
00888937000078
Brand
Prima Series® Vaginal Speculum
Company
Coopersurgical, Inc.
Model
PSV-1L
Device description
Prima Series® Vaginal Speculum • Medium
Published
2016-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K951898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951898000VERSA-VUCooperSurgical, Inc.1995-12-11HIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937000078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937000078008889370000788889370000780888937000078

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA 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 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 at an angle. It is typically made of stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization"", ""Liquid Chemical""]"
Ethylene Oxide;Moist Heat or Steam Sterilization;Liquid Chemical

Regulatory Flags#

DUNS number
801895244
Device count
1
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937033687ONETRACC1001502026-07-10
00888937033694ONETRACC1001652026-07-10
00888937033700ONETRACC1001702026-07-10
00888937033717ONETRACC1001802026-07-10
00888937033724ONETRACC1001902026-07-10
00888937033731ONETRAC LXC1002102026-07-10
00888937033748ONETRAC LXC1002202026-07-10
00888937033755ONETRAC LXC1002302026-07-10
00888937033762ONETRAC LXC1002402026-07-10
00888937033779ONETRAC LXC1002502026-07-10
00888937033786ONETRAC™ LXSC1002602026-07-10
00888937033793ONETRAC™ LXSC1002702026-07-10
00888937033809ONETRAC™ LXSC1002802026-07-10
00888937033816ONETRAC™ LXSC1002902026-07-10
00888937033823ONETRAC™ LXSC1102002026-07-10
00888937033830ONETRAC™ LXSC1102102026-07-10
00888937033847ONETRAC™ LXSC1102202026-07-10
00888937033854ONETRAC™ LXSC1103102026-07-10
00888937033861ONETRAC™ LXSC1103202026-07-10
00888937033663ONETRAC™C1001102026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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