Duns Number:835465063
Device Description: BUR 31112075 2MMX75MM CRSE DIAMOND
Catalog Number
-
Brand Name
N/A
Version/Model Number
31112075
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
EQJ
Product Code Name
BUR, EAR, NOSE AND THROAT
Public Device Record Key
b555ca44-838a-4664-9b7f-5856454534ed
Public Version Date
October 09, 2020
Public Version Number
3
DI Record Publish Date
September 09, 2017
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 | 665 |
2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
3 | A medical device with high risk that requires premarket approval | 6 |
U | Unclassified | 10 |