Duns Number:079641356
Device Description: Ultracut Scissors, 5 mm, 33 cm, Curved, Non Locking
Catalog Number
95-2006
Brand Name
Symmetry Metzenbaum
Version/Model Number
95-2006
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 9999
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
K946263
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
0be825c7-54d1-4971-b2a3-0d782209742e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
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 | 7981 |
2 | A medical device with a moderate to high risk that requires special controls. | 3309 |