Duns Number:016898496
Device Description: PVC Drain with Trocar, Large 1/4" (19 Fr., 6.3mm) O.D., 12.5" (31.7cm) Hole Pattern, X-Ray PVC Drain with Trocar, Large 1/4" (19 Fr., 6.3mm) O.D., 12.5" (31.7cm) Hole Pattern, X-Ray Opaque Stripe, with Attached Trocar
Catalog Number
0080730
Brand Name
PVC Drain with Trocar
Version/Model Number
0080730
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
330b34cf-21c3-442b-bba5-f5e9b47feba7
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
10801741050142
Quantity per Package
10
Contains DI Package
00801741050145
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 |