Duns Number:812762226
Device Description: 1 arm(s) DLZL-11-350 6/0 PA Nylon black 45cm
Catalog Number
OL351150
Brand Name
Onatec
Version/Model Number
OL351150
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
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
358e5e04-d327-4de2-bdd4-f47fc924a8de
Public Version Date
May 20, 2022
Public Version Number
2
DI Record Publish Date
April 25, 2022
Package DI Number
10848782032942
Quantity per Package
12
Contains DI Package
00848782032945
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 |