Duns Number:106135367
Device Description: Ceramic Kerrison Rongeur 8", 4.0mm tip with ejector standard Footplate
Catalog Number
ACE08-40S EX
Brand Name
Ace Medical
Version/Model Number
ACE08-40S EX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K200387
Product Code
HAE
Product Code Name
Rongeur, Manual
Public Device Record Key
e6db5307-e30d-4c46-87a7-09145c0bcbb1
Public Version Date
September 15, 2022
Public Version Number
3
DI Record Publish Date
March 29, 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 | 338 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 376 |