Duns Number:070666290
Device Description: A single use, plastic, rigid, cone shaped, speculum designed specifically for use with the A single use, plastic, rigid, cone shaped, speculum designed specifically for use with the WiscMed Wispr digital otoscope. This item number consists of a quantity of 300 specula, packaged in plastic sleeves designed to fit traditional wall mounted specula holders found in most patient exam rooms.
Catalog Number
-
Brand Name
WiscMed
Version/Model Number
spec1-300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EPY
Product Code Name
Speculum, Ent
Public Device Record Key
c421f9cd-5c54-4b38-9d91-c80934a84690
Public Version Date
April 06, 2020
Public Version Number
1
DI Record Publish Date
March 27, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |