Duns Number:298725490
Device Description: Suction Tube
Catalog Number
UK10-197F
Brand Name
EXMOOR
Version/Model Number
UK10-197F
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JZF
Product Code Name
Tube, Ear Suction
Public Device Record Key
a175fdaa-ab1e-48b6-9f04-1f52de999f23
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
September 13, 2018
Package DI Number
05060180250157
Quantity per Package
50
Contains DI Package
05060180258351
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
a box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 245 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |