Duns Number:063519193
Device Description: Medi-Inn Probe Covers Clear Polyethylene Sterile 6.5in x 54in x .002in 100 per Case
Catalog Number
-
Brand Name
Medi-INN
Version/Model Number
MI-100MILCDN
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"
Yes
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
IYO
Product Code Name
System, Imaging, Pulsed Echo, Ultrasonic
Public Device Record Key
7ee32e15-d3b5-427a-a624-d77c5ed19c29
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 25, 2022
Package DI Number
10618125175687
Quantity per Package
100
Contains DI Package
00618125175680
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |