FDA.reportPublic FDA data

Gynescope single use vaginal speculume size small 60 units

Primary DI
27290018240018
Brand
Gynescope single use vaginal speculume size small 60 units
Company
ILLUMIGYN LTD
Model
01
Catalog number
IL-100-200-210
Device description
Indications for UseGynescope single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope™ system.
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

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
27290018240018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729001824001827290018240018

GMDN Terms#

Term, Definition table
TermDefinition
Video colposcope speculumA hand-held manual instrument, into which a video colposcope camera unit is placed, intended to dilate the vagina after insertion for visual examination of the tissues of the vagina, cervix, and external genitalia. It consists of two blades which can be opened at the distal end, and a cradle for attaching the camera in the handle-like proximal end; the camera is connected to a video colposcope camera/monitor (not included). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97225476319support@illumigyn.com

Regulatory Flags#

DUNS number
600627621
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
57290018240026Gynescope, console system01IL-100-100-1002020-11-26
67290018240016Gynescope Image acquistion system01IL-100-100-2002020-11-26
77290018240013Gynescope system, cart01IL-100-100-9002020-11-26
17290018240011GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs01IL-100-100-0002020-11-20
37290018240015Gynescope single use vaginal speculum size medium 60 units01IL-100-200-3102020-09-25
47290018240012Gynescope single use vaginal speculum size large 60 units01IL-100-200-4102020-09-25
57290018240019Gynescope single use vaginal speculum size Sm + Md + Lrg 20 pcs each01IL-100-200-5002020-09-25

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Primary DI, Brand, Company table
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00199536930117BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00888937027389OfficeSPECCoopersurgical, Inc.HIB2026-08-06
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00888937027426ER-SPECCoopersurgical, Inc.HIB2026-08-06
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