Duns Number:041434170
Device Description: 5.5-6µm OD, 4.0µm ID, 20-25° Tip Bevel, 20° Neck Angle, 1mm Tip to Elbow, Smooth Jaw, Spik 5.5-6µm OD, 4.0µm ID, 20-25° Tip Bevel, 20° Neck Angle, 1mm Tip to Elbow, Smooth Jaw, Spiked
Catalog Number
AI4020-YL
Brand Name
ASTEC
Version/Model Number
ICSI Injection Pipette
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
Yes
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
PUC
Product Code Name
Microtools, Assisted Reproduction (Pipettes), Exempt
Public Device Record Key
a2273418-76ba-473e-abdb-02c9028e025f
Public Version Date
November 20, 2020
Public Version Number
1
DI Record Publish Date
November 12, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |