Duns Number:001406024
Device Description: Absorbable Synthetic Implants 1 Pair 0.4mm X 2.0mm
Catalog Number
A13-2044SP
Brand Name
EXTEND 180™
Version/Model Number
A13-2044SP
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
LZU
Product Code Name
Plug, Punctum
Public Device Record Key
cbf1a2d8-506c-4732-ba74-6755564baf6f
Public Version Date
February 08, 2022
Public Version Number
1
DI Record Publish Date
January 31, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 441 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |
| U | Unclassified | 34 |