Duns Number:011560431
Device Description: VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE EXTRA SMALL
Catalog Number
-
Brand Name
ER-SPEC/OFFICE-SPEC
Version/Model Number
C020130-1
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"
-
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
K091937,K091937,K091937
Product Code
HIB
Product Code Name
Speculum, Vaginal, Nonmetal
Public Device Record Key
18aa3fec-4403-49fb-be86-9a079511513e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 28, 2017
Package DI Number
M648C02013012
Quantity per Package
4
Contains DI Package
M648C02013011
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 |