Duns Number:055870299
Device Description: Microdissection Tungsten Ndl.5 7/8" (14.9cm) Cvd. 45', Single Usenon sterile
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.28139
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K895331
Product Code
JOS
Product Code Name
Electrode, Electrosurgical
Public Device Record Key
98bb4a48-a638-4d89-b9e2-c41d4208530a
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 25, 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 | 1975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 400 |