Duns Number:219683489
Device Description: 2030 NOSE CLIPS
Catalog Number
-
Brand Name
Noseclip
Version/Model Number
2030
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
BXJ
Product Code Name
CLIP, NOSE
Public Device Record Key
4b233451-e2a4-4958-8e49-0ddbb9b61284
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
December 05, 2016
Package DI Number
55099169202516
Quantity per Package
40
Contains DI Package
05099169202511
Package Discontinue Date
-
Package Status
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 | 10 |
2 | A medical device with a moderate to high risk that requires special controls. | 189 |