Duns Number:645680588
Device Description: Intended Use: Graves Vaginal Speculum is a gynecological instrument used for performing pe Intended Use: Graves Vaginal Speculum is a gynecological instrument used for performing pelvic examinations, Pap Smears, and examining the cervixPackaging: Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50.
Catalog Number
SU-21-0040-03
Brand Name
Graves Speculum
Version/Model Number
SU-21-0040-03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HDF
Product Code Name
Speculum, Vaginal, Metal
Public Device Record Key
bc19a8f4-dd5f-4497-9349-bb8c5d3a5813
Public Version Date
September 16, 2022
Public Version Number
1
DI Record Publish Date
September 08, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38 |