Duns Number:964459106
Device Description: Pick & Shape Perforated Foam - Convolute Medium Square - 2" (1" x 1" Pick Square Size)
Catalog Number
PSPF-CM12122
Brand Name
Packaging Products
Version/Model Number
PSPF-CM12122
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"
Yes
For Single-Use
Yes
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
da1d7807-0401-49d5-9b07-4867a4ee93b5
Public Version Date
August 06, 2020
Public Version Number
1
DI Record Publish Date
July 29, 2020
Package DI Number
00810044961393
Quantity per Package
12
Contains DI Package
10810044961390
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 | 148 |