Duns Number:079636174
Device Description: sterile bags
Catalog Number
925.OAKWLSB
Brand Name
Bone Foam, Inc.
Version/Model Number
925.OAKWLSB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 2018
Issuing Agency
In HIBCC
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"
Yes
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
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
afd2e46c-7839-47a6-bcb1-bd4844bc36e3
Public Version Date
April 06, 2022
Public Version Number
3
DI Record Publish Date
October 10, 2016
Package DI Number
B197925OAKWLSB1
Quantity per Package
20
Contains DI Package
B197925OAKWLSB0
Package Discontinue Date
November 01, 2018
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 97 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |