Duns Number:313267265
Device Description: Tissue Protector for Drill 7.0 and Over-Drill 7.0 color-coated purple non-sterile
Catalog Number
-
Brand Name
N/A
Version/Model Number
CH15042
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 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
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
6b26c46e-e29a-49a2-ad1c-43766beb566a
Public Version Date
October 20, 2022
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 |