Duns Number:130213366
Device Description: Zeiss Pico adapter for micromanipulators.
Catalog Number
-
Brand Name
Accu-Beam
Version/Model Number
7021
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K864378
Product Code
HHR
Product Code Name
Laser, Surgical, Gynecologic
Public Device Record Key
bad43a3b-f40c-4d61-8450-01c8b07e5cad
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 06, 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 | 134 |
2 | A medical device with a moderate to high risk that requires special controls. | 303 |