Duns Number:190094230
Device Description: HTF culture medium is a synthetic, defined culture medium intended for use in assisted rep HTF culture medium is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. HTF uses a sodium bicarbonate buffering system and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation.
Catalog Number
2001
Brand Name
HTF culture medium
Version/Model Number
2001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K993484
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
7e753566-97fd-4b32-8ea4-c2a25936b728
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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. | 29 |