Duns Number:017246562
Device Description: PLASTIC SUTURING SET
Catalog Number
SUT11895
Brand Name
Centurion
Version/Model Number
SUT11895
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
e1b08998-f11a-4138-87e1-0a2b29f7b42b
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
January 02, 2022
Package DI Number
10653160231288
Quantity per Package
15
Contains DI Package
00653160231281
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 |