Duns Number:080530675
Device Description: PAN-A-CAPE APRON BLUE
Catalog Number
29BLUE
Brand Name
Palmero Healthcare, LLC
Version/Model Number
29BLUE
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EAJ
Product Code Name
Apron, leaded
Public Device Record Key
bfe7f887-9111-41a3-8165-28db65cffd70
Public Version Date
March 12, 2021
Public Version Number
1
DI Record Publish Date
March 04, 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 | 740 |