Duns Number:016898496
Device Description: Hubless Silicone Flat Drain, 7mm Wide (1/4" approx), 20cm Long (7.9" approx), Full Length Hubless Silicone Flat Drain, 7mm Wide (1/4" approx), 20cm Long (7.9" approx), Full Length Perforations, X-Ray Opaque Stripe
Catalog Number
0070430
Brand Name
Silicone Flat Drain
Version/Model Number
0070430
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
549393a7-414b-4acc-853a-a756cc565929
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
10801741090759
Quantity per Package
10
Contains DI Package
00801741090752
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 |