Duns Number:313267265
Device Description: BioBall Extractor Sleeve for Adapter 12/14 S and MSPC M-L non-sterile
Catalog Number
-
Brand Name
BioBall™
Version/Model Number
HM20002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 13, 2021
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
HWB
Product Code Name
EXTRACTOR
Public Device Record Key
2600dd69-a786-4eb6-ba66-2a2f352794dd
Public Version Date
December 14, 2021
Public Version Number
2
DI Record Publish Date
November 01, 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 | 328 |
2 | A medical device with a moderate to high risk that requires special controls. | 1327 |
U | Unclassified | 13 |