Duns Number:486711679
Device Description: CRANIOS REINFORCED ROTARY MIX 3CC-STERILE
Catalog Number
6160301S
Brand Name
CRANIOS Reinforced
Version/Model Number
616.03.01S
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
K102018
Product Code
GXP
Product Code Name
METHYL METHACRYLATE FOR CRANIOPLASTY
Public Device Record Key
6e17f5c4-3b85-439c-8d6f-91eac128933a
Public Version Date
April 26, 2022
Public Version Number
6
DI Record Publish Date
September 14, 2015
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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |