Duns Number:008503294
Device Description: POSEY FOAM LIMB HOLDER/QR
Catalog Number
2533
Brand Name
POSEY
Version/Model Number
2533
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
FMQ
Product Code Name
Restraint, Protective
Public Device Record Key
1fcc22e8-5cb6-4920-a74f-5cc6f5be9a4a
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 2022
Package DI Number
20190676005301
Quantity per Package
48
Contains DI Package
10190676005304
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 177 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |