Duns Number:121979777
Device Description: NYL.PLAS.SR BKL.N/SWVL.SC 5'
Catalog Number
1265YL
Brand Name
MORRISON MEDICAL
Version/Model Number
1265YL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMQ
Product Code Name
Restraint, Protective
Public Device Record Key
fb2b11ef-2977-4762-bb2c-09332241541a
Public Version Date
November 15, 2019
Public Version Number
2
DI Record Publish Date
September 27, 2019
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 | 1029 |