Duns Number:039709088
Device Description: Blastomere Biopsy Pipette
Catalog Number
-
Brand Name
SLM
Version/Model Number
SBB-30Z-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
K092554,K092554
Product Code
MQH
Product Code Name
Microtools, Assisted Reproduction (Pipettes)
Public Device Record Key
37507a45-660d-4e77-8e13-4a12b9557cb9
Public Version Date
November 25, 2019
Public Version Number
1
DI Record Publish Date
November 15, 2019
Package DI Number
30816633023467
Quantity per Package
10
Contains DI Package
10816633023463
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 |