Duns Number:078573265
Device Description: Graft cleaning bowl used in the cleaning of follicles removed from the donor area before t Graft cleaning bowl used in the cleaning of follicles removed from the donor area before they are entered into the recipient area.
Catalog Number
630.000
Brand Name
Graft Cleaning Bowl
Version/Model Number
Graft Cleaning Bowl
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
-
Product Code
IDX
Product Code Name
Sieves, Tissue
Public Device Record Key
27d6ac9d-0d59-4eb4-ad4b-955e2b16501f
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 14, 2021
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 75 |