Duns Number:040729840
Device Description: NASAL/TONSIL WIRE SNARES SIZE 4
Catalog Number
485-736
Brand Name
NASAL/TONSIL WIRE SNARES
Version/Model Number
485-736
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KBE
Product Code Name
SNARE, NASAL
Public Device Record Key
158a8197-f036-4a95-bbb5-d687e1a5d729
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 14, 2018
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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |