Duns Number:007131725
Device Description: HG SST ROD 1.35/1.25OD SNAPFIT
Catalog Number
113623
Brand Name
2726 HEAD SUPPORT
Version/Model Number
2726
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
JAY
Product Code Name
Support, Breathing Tube
Public Device Record Key
c7edc373-f40f-4a7c-8ecf-c8f15ccf156a
Public Version Date
August 18, 2021
Public Version Number
1
DI Record Publish Date
August 10, 2021
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 | 922 |
2 | A medical device with a moderate to high risk that requires special controls. | 407 |