Duns Number:612611459
Device Description: Cranitomy Kit Consisting of Qty 1 - D810607000057 Cranial Perforator Catalog# 200-253, QTY Cranitomy Kit Consisting of Qty 1 - D810607000057 Cranial Perforator Catalog# 200-253, QTY 1 - DI 810607000408 Cranial Blade Catalog# 800-140 & QTY 1 -DI 810607000422 Wire Pass Drill Catalog# 800-330.
Catalog Number
400-109
Brand Name
Cranitomy Kit Disposable Low Speed
Version/Model Number
400-109
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
d54da5b5-9ddc-46b0-bdf0-67aa77faed61
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 01, 2017
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |