Duns Number:315142027
Device Description: MULTI-BITE KERRISON RONGEUR 3 MM BITE SIZE, 14 MM OPEN, 200 MM (7.9") LENGTH, SINGLE-USE, MULTI-BITE KERRISON RONGEUR 3 MM BITE SIZE, 14 MM OPEN, 200 MM (7.9") LENGTH, SINGLE-USE, STERILE
Catalog Number
-
Brand Name
PHANTOM MULTI-BITE KERRISON RONGEUR
Version/Model Number
KR-2003
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
Yes
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
HAE
Product Code Name
Rongeur, Manual
Public Device Record Key
2eec8728-b7bb-439b-b88b-f17e59b64db7
Public Version Date
July 06, 2022
Public Version Number
1
DI Record Publish Date
June 28, 2022
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |