Duns Number:018238010
Device Description: Squid compression device left shoulder full unit
Catalog Number
-
Brand Name
Squid
Version/Model Number
Left Shoulder
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IME
Product Code Name
Pack, Hot Or Cold, Reuseable
Public Device Record Key
d481da2b-e58c-4951-b6bc-62b7650ac973
Public Version Date
May 12, 2021
Public Version Number
3
DI Record Publish Date
July 06, 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 | 30 |