Duns Number:015272206
Device Description: Kerrison swivel take-a-part rongeur, working length 250mm, regular footplate, angled up 90 Kerrison swivel take-a-part rongeur, working length 250mm, regular footplate, angled up 90 degrees, 1.0mm bite, small handle
Catalog Number
99-210
Brand Name
Ambler Surgical
Version/Model Number
Kerrison swivel take-a-part rongeur
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
-
Product Code
LRY
Product Code Name
PUNCH, SURGICAL
Public Device Record Key
da6cd6b9-9a26-462c-a3ae-702cd6344a14
Public Version Date
January 15, 2021
Public Version Number
1
DI Record Publish Date
January 07, 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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |