Catalog Number
38807
Brand Name
NA
Version/Model Number
388.07
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 17, 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
-
Product Code
HWX
Product Code Name
TAP, BONE
Public Device Record Key
2f39c6ec-fe54-4800-bf2b-8b0d70424e4c
Public Version Date
September 17, 2020
Public Version Number
6
DI Record Publish Date
December 31, 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 | 1194 |
2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
3 | A medical device with high risk that requires premarket approval | 30 |
U | Unclassified | 1 |