Duns Number:006261481
Device Description: TRILLIUM BIO PROBE DP38PT 1/4 10PK
Catalog Number
-
Brand Name
Trillium™
Version/Model Number
DP38PT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132730,K132730
Product Code
DPT
Product Code Name
PROBE, BLOOD-FLOW, EXTRAVASCULAR
Public Device Record Key
d308f80f-6465-41b0-b894-7f40586aea10
Public Version Date
December 13, 2018
Public Version Number
4
DI Record Publish Date
January 03, 2017
Package DI Number
20643169767014
Quantity per Package
10
Contains DI Package
00643169767003
Package Discontinue Date
October 05, 2018
Package Status
Not in Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |