Duns Number:011560431
Device Description: SINGLE-SIDED VAGINAL SPECULUM WITH LIGHT SINGLE-USE SIZE MEDIUM
Catalog Number
C020001
Brand Name
OFFICESPEC
Version/Model Number
C020001
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
K091937,K091937,K091937
Product Code
HIB
Product Code Name
Speculum, Vaginal, Nonmetal
Public Device Record Key
b40f2846-9384-4468-be15-b8ccd5857282
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
M648C0200012
Quantity per Package
4
Contains DI Package
M648C0200011
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 |