Duns Number:071595540
Device Description: OSTEOPREP STERILIZATION TRAY
Catalog Number
8217
Brand Name
OSTEOPREP
Version/Model Number
8217
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2020
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
K052992,K052992
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
97ae2a51-e516-42c1-91a2-c0c17de1126b
Public Version Date
September 16, 2022
Public Version Number
11
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |