Duns Number:047644935
Device Description: RELIEF Deluxe Straight Metz Scissor, Serrated Blades, 5mm x 45cm
Catalog Number
91465-D-RLF-45
Brand Name
Mediflex Deluxe Laparoscopic Instruments
Version/Model Number
91465-D-RLF-45
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K974382
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
4565c867-73f3-4b56-8cbb-e171b4ad43d3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 20, 2017
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 | 882 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |