Duns Number:812762226
Device Description: 2xDLZ-8.0-300 USP 5-0 Polyester white 45 cm. sterile VA6.1
Catalog Number
GDT5F8011
Brand Name
DYNEK
Version/Model Number
GDT5F8011
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
-
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
d9ddb9ce-0aad-4957-af27-0bd65e8134bc
Public Version Date
November 01, 2021
Public Version Number
1
DI Record Publish Date
October 22, 2021
Package DI Number
10848782042026
Quantity per Package
12
Contains DI Package
00848782042029
Package Discontinue Date
-
Package Status
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 | 300 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2030 |
| U | Unclassified | 19 |