Duns Number:825673239
Device Description: 2000ML RECEPTAL™ LINER WITH POUR SPOUT
Catalog Number
430270411
Brand Name
2000ML RECEPTAL™ LINER WITH POUR SPOUT
Version/Model Number
1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
fc437453-95e5-4698-a28c-492b713183f6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
40704411000151
Quantity per Package
5
Contains DI Package
20704411000157
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 | 89 |
2 | A medical device with a moderate to high risk that requires special controls. | 411 |
U | Unclassified | 1 |