Duns Number:600627621
Device Description: 20 units with small size20 units with medium size20 units with lager size.Indications for 20 units with small size20 units with medium size20 units with lager size.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.
Catalog Number
IL-100-200-500
Brand Name
Gynescope single use vaginal speculum size Sm + Md + Lrg 20 pcs each
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HIB
Product Code Name
Speculum, Vaginal, Nonmetal
Public Device Record Key
8f1f1e95-a001-4ef7-85a5-525151a7a454
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |