Duns Number:483016148
Device Description: LOW-PROFILE IMPLANT HOLDER
Catalog Number
SCA-IC 11 05-N
Brand Name
SCARLET AC-T INSTRUMENTATION
Version/Model Number
SCA-IC 11 05-N
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
OVE
Product Code Name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Public Device Record Key
669873b0-644c-4923-bd1c-3de6b5ed0802
Public Version Date
April 21, 2021
Public Version Number
3
DI Record Publish Date
February 12, 2019
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 | 974 |
2 | A medical device with a moderate to high risk that requires special controls. | 5209 |