Duns Number:829465157
Device Description: Retention Suture Bridge
Catalog Number
450G
Brand Name
ETHICON
Version/Model Number
450G
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 20, 2022
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)
Yes
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
-
Product Code
KGS
Product Code Name
RETENTION DEVICE, SUTURE
Public Device Record Key
fcbbbb85-7da3-4fb2-816b-399e37935649
Public Version Date
July 21, 2022
Public Version Number
5
DI Record Publish Date
September 01, 2015
Package DI Number
30705031005529
Quantity per Package
12
Contains DI Package
10705031005525
Package Discontinue Date
July 20, 2022
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |