Duns Number:039709088
Device Description: ICSI Injection Pipette
Catalog Number
-
Brand Name
SLM
Version/Model Number
SIC-45T-30R
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K072600,K072600
Product Code
MQH
Product Code Name
Microtools, Assisted Reproduction (Pipettes)
Public Device Record Key
c00eb59d-97f4-4ed3-80c0-e2c3da02421e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
30816633021418
Quantity per Package
10
Contains DI Package
10816633021414
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 221 |