Duns Number:305971764
Device Description: NUNC IVF MULTIDISH4 WELL NON-TREATED
Catalog Number
-
Brand Name
NUNC IVF MULTIDISH4 WELL NON-TREATED
Version/Model Number
179830
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
-
Product Code
PUD
Product Code Name
Labware, Assisted Reproduction, Exempt
Public Device Record Key
42c1551a-ebed-4721-8059-11f32a0f2e9f
Public Version Date
May 28, 2021
Public Version Number
3
DI Record Publish Date
September 21, 2018
Package DI Number
35713311000169
Quantity per Package
30
Contains DI Package
15713311000165
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |