Duns Number:053146767
Device Description: SH 7-47 Nose Clip holds patient's nostrils closed during testing and treatment. Single Pa SH 7-47 Nose Clip holds patient's nostrils closed during testing and treatment. Single Patient Use.
Catalog Number
SH 7-47
Brand Name
SH 7-47 Nose Clip
Version/Model Number
SH 7-47
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
BXJ
Product Code Name
Clip, Nose
Public Device Record Key
4a73fb62-9dbb-409f-a458-0c2d3328ed04
Public Version Date
May 06, 2019
Public Version Number
1
DI Record Publish Date
April 26, 2019
Package DI Number
M996SH7476
Quantity per Package
100
Contains DI Package
M996SH7470
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |