Duns Number:016898496
Device Description: Hubless Silicone Flat Drain, 10mm Wide, 20cm Long, 3/4 Length Perforations, X-Ray Opaque S Hubless Silicone Flat Drain, 10mm Wide, 20cm Long, 3/4 Length Perforations, X-Ray Opaque Stripe
Catalog Number
0070370
Brand Name
Silicone Flat Drain
Version/Model Number
0070370
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
4da357d8-6494-4ce6-9f2b-80b9f18ac2bd
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
10801741090742
Quantity per Package
10
Contains DI Package
00801741090745
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 |