Duns Number:017246562
Device Description: SUTURE REPAIR TRAY
Catalog Number
60330
Brand Name
Centurion
Version/Model Number
60330
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"
Yes
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
-
Product Code
KDD
Product Code Name
Kit, surgical instrument, disposable
Public Device Record Key
90a0f607-6350-42c7-b286-55ef795cddc6
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
December 31, 2021
Package DI Number
10653160107699
Quantity per Package
30
Contains DI Package
00653160107692
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6043 |
2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
U | Unclassified | 1 |