Duns Number:305524696
Device Description: Suture Delivery Device
Catalog Number
52025
Brand Name
Digitex
Version/Model Number
52025
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
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
K093112,K093112
Product Code
HCF
Product Code Name
INSTRUMENT, LIGATURE PASSING AND KNOT TYING
Public Device Record Key
b252c5aa-745c-4997-9cda-dc68c9cca74d
Public Version Date
December 04, 2020
Public Version Number
6
DI Record Publish Date
October 28, 2015
Package DI Number
05708932440134
Quantity per Package
12
Contains DI Package
05708932440127
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |