Duns Number:011560431
Device Description: VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE EXTRA LARGE
Catalog Number
-
Brand Name
ER-SPEC
Version/Model Number
C020140-1
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"
Yes
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
8cc9bb56-ee72-4877-a294-8fecfcf12ea6
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 28, 2018
Package DI Number
M648C02014012
Quantity per Package
4
Contains DI Package
M648C02014011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |