Duns Number:044606982
Device Description: ENDOPATH 5mm Endoscopic Blunt Tip Dissectors (12 Pouches Containing 3 Dissectors each)
Catalog Number
BTD05
Brand Name
ENDOPATH
Version/Model Number
BTD05
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
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
55e2db83-7a9a-45c6-80dd-85530d94bf5c
Public Version Date
October 16, 2019
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
30705036011877
Quantity per Package
72
Contains DI Package
10705036011873
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |