Duns Number:327681359
Device Description: TITANIUM MICRO NEEDLE HOLDER, CURVED TIPS 9,0 MM X 0,3 MM TOTAL LENGTH 180 MM / 7" FLAT HA TITANIUM MICRO NEEDLE HOLDER, CURVED TIPS 9,0 MM X 0,3 MM TOTAL LENGTH 180 MM / 7" FLAT HANDLE
Catalog Number
64.546.14 T
Brand Name
LAZIC
Version/Model Number
64.546.14 T
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
-
Product Code
HYA
Product Code Name
Forceps, Wire Holding
Public Device Record Key
d3538041-6c49-4540-8cfd-8d1ee1267b71
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
June 17, 2020
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 | 1084 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1125 |