Duns Number:536139413
Device Description: Assisted Reproduction Micromanipulator and Microinjector
Catalog Number
6-54-100-18
Brand Name
INTEGRA 3
Version/Model Number
Integra 3 Thermosafe Olympus IX1 No Syringes
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
K003142
Product Code
MQJ
Product Code Name
Micromanipulators and microinjectors, assisted reproduction
Public Device Record Key
1fe5d29f-c334-401d-b6c0-15d71aa9aae4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 23, 2018
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. | 68 |