Duns Number:079991657
Device Description: 1/8" PVC Drain & Trocar
Catalog Number
2062
Brand Name
BOEHRINGER® 1/8" PVC Drain & Trocar
Version/Model Number
2062
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 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"
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
CAC
Product Code Name
Apparatus, Autotransfusion
Public Device Record Key
c1fbf117-2fb9-4b8c-90bd-26a5ecd90133
Public Version Date
March 08, 2022
Public Version Number
5
DI Record Publish Date
August 01, 2016
Package DI Number
50816286020695
Quantity per Package
12
Contains DI Package
10816286020697
Package Discontinue Date
December 31, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 85 |