Duns Number:190572854
Device Description: LUPINE LOOP ANCHOR Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD LUPINE LOOP ANCHOR Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braided Composite Suture, 36 Inches (91cm). Size 2 (5 metric) ORTHOCORD eyelet loop.
Catalog Number
222980
Brand Name
LUPINE ORTHOCORD
Version/Model Number
222980
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 28, 2021
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
K040827
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
5115c24d-20fa-4134-aee1-db21d84f1c87
Public Version Date
January 28, 2021
Public Version Number
7
DI Record Publish Date
September 01, 2015
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 | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |