Duns Number:068199363
Catalog Number
-
Brand Name
RAPICIDE PA PART A 3X5
Version/Model Number
ML02-PTA13
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
K082988,K082988
Product Code
FEB
Product Code Name
Accessories, Cleaning, For Endoscope
Public Device Record Key
fc3ee563-4144-47d3-b7f4-82f1370f8b41
Public Version Date
April 06, 2022
Public Version Number
6
DI Record Publish Date
February 26, 2021
Package DI Number
40677964021389
Quantity per Package
3
Contains DI Package
40677964023604
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2999 |
2 | A medical device with a moderate to high risk that requires special controls. | 362 |