Duns Number:830350380
Device Description: LABEL 1208888 PEEK PREVAIL CASE
Catalog Number
-
Brand Name
N/A
Version/Model Number
1208888
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
K094042
Product Code
ODP
Product Code Name
Intervertebral fusion device with bone graft, cervical
Public Device Record Key
14e9a54f-8bd7-47d8-bbdf-af0dbf80be3b
Public Version Date
September 16, 2022
Public Version Number
9
DI Record Publish Date
April 07, 2016
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 | 13352 |
2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
3 | A medical device with high risk that requires premarket approval | 190 |
U | Unclassified | 75 |