Duns Number:106908437
Device Description: PROBE COVER, ROLLED, W/RUBBERBANDS, 1.4" X 8"
Catalog Number
-
Brand Name
MICROTEK
Version/Model Number
1
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)
Yes
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
K961029,K961029
Product Code
IYO
Product Code Name
System, imaging, pulsed echo, ultrasonic
Public Device Record Key
33ff90ee-2cc3-4f12-9e15-8a9ec6c40878
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
January 23, 2017
Package DI Number
50748426054027
Quantity per Package
50
Contains DI Package
30748426053781
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 919 |