Duns Number:190572854
Device Description: BIOKNOTLESS BR Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor, size 2 (5 metric) ORTHOCORD BIOKNOTLESS BR Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor, size 2 (5 metric) ORTHOCORD braided composite suture anchor loop, size 2/0 green ETHIBOND suture utility loop.
Catalog Number
212722
Brand Name
BIOKNOTLESS ORTHOCORD ETHIBOND
Version/Model Number
212722
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
K070925
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
0a4d3f47-6234-4d12-b6f8-a0eafd22b39b
Public Version Date
March 21, 2019
Public Version Number
5
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 |