Duns Number:016898496
Device Description: Abramson Triple Lumen Sump Drain, .67" Width (1.7cm), 15" Length (38cm), Silicone, With Fi Abramson Triple Lumen Sump Drain, .67" Width (1.7cm), 15" Length (38cm), Silicone, With Filter, X-ray Opaque Stripe
Catalog Number
0080450
Brand Name
Triple Lumen Sump Drain
Version/Model Number
0080450
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
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
ef7d1589-67cb-4903-9a90-74f14ebf75ae
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
10801741050098
Quantity per Package
5
Contains DI Package
00801741050091
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |