Duns Number:825673239
Device Description: RECEPTAL™ CANISTER SUPPORT FOR 1000 ML 1500 ML AND 2000 ML
Catalog Number
43426P8201
Brand Name
RECEPTAL™ CANISTER SUPPORT FOR 1000 ML 1500 ML AND 2000 ML
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"
-
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
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
778cfcb5-2188-43bc-8973-9cf88f1be819
Public Version Date
May 28, 2018
Public Version Number
1
DI Record Publish Date
April 25, 2018
Package DI Number
40704411007716
Quantity per Package
20
Contains DI Package
10704411007715
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 |