Duns Number:040729840
Device Description: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE
Catalog Number
-
Brand Name
HEARTLINE NEEDLE HOLDER
Version/Model Number
2800-035S
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
-
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
K152400
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
c7742f87-ec08-4fcc-bed1-d5cb10535b05
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
August 22, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |