Duns Number:106908437
Device Description: "INTRAOPERATIVE PROBE COVER W/O GEL, 5"" X 96"""
Catalog Number
-
Brand Name
MICROTEK
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 18, 2017
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K882724,K882724,K882724
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
436ed124-525b-4760-9b9b-dc1805584825
Public Version Date
January 25, 2021
Public Version Number
5
DI Record Publish Date
March 22, 2017
Package DI Number
30802526579609
Quantity per Package
20
Contains DI Package
00802526579608
Package Discontinue Date
July 18, 2017
Package Status
Not 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 |