Duns Number:094651270
Device Description: PALATE GUARD Sampler kit, Palate Protection for Neonates, W/ 2 - EXTRA SMALL, 3 - SMALL, 3 PALATE GUARD Sampler kit, Palate Protection for Neonates, W/ 2 - EXTRA SMALL, 3 - SMALL, 3 - MEDIUM, & 2 - LARGE
Catalog Number
4005000
Brand Name
PALA-NATE
Version/Model Number
Sampler Kit
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K923591
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
4943dcb9-05c3-46a4-89e0-fc547d2e1bf1
Public Version Date
December 18, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |