Duns Number:015272206
Device Description: McCabe perforation rasp, 6 1/8'', straight shaft, angled 45 degrees, rasp on inside of bla McCabe perforation rasp, 6 1/8'', straight shaft, angled 45 degrees, rasp on inside of blade, flat handle
Catalog Number
69-640
Brand Name
Ambler Surgical
Version/Model Number
McCabe perforation rasp
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
349de5e7-783b-4f40-ae6b-1332c2aa1604
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 |