Duns Number:015272206
Device Description: Saunders-Paparella window rasp and marker, 6 1/2'', malleable, straight shaft, straight, m Saunders-Paparella window rasp and marker, 6 1/2'', malleable, straight shaft, straight, mushroom shaped rasp, with markings at 4.0mm, 4.5mm and 5.0mm, hexagonal handle
Catalog Number
69-950
Brand Name
Ambler Surgical
Version/Model Number
Saunders-Paparella window rasp and marker
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
KBA
Product Code Name
RASP, NASAL
Public Device Record Key
de9f8089-a190-4eba-a3a8-5abf365bc985
Public Version Date
June 10, 2022
Public Version Number
2
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 |