Duns Number:196880520
Device Description: KIT, PANEL, PL691, 5-PCS
Catalog Number
RP131K
Brand Name
KIT, PANEL, PL691, 5-PCS
Version/Model Number
RP131K
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
IQA
Product Code Name
SYSTEM, ENVIRONMENTAL CONTROL, POWERED
Public Device Record Key
29bca8a6-1ad4-472d-bdb6-856ca4b09bb2
Public Version Date
September 03, 2021
Public Version Number
2
DI Record Publish Date
July 10, 2021
Package DI Number
00812664024137
Quantity per Package
5
Contains DI Package
00812664023710
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Usage 1, 5 per pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 51 |
2 | A medical device with a moderate to high risk that requires special controls. | 94 |