Duns Number:190572854
Device Description: BIOKNOTLESS RC Anchor w/PANACRYL PLA Absorbable Anchor, Size 1 (4 metric) PANACRYL braided BIOKNOTLESS RC Anchor w/PANACRYL PLA Absorbable Anchor, Size 1 (4 metric) PANACRYL braided absorbable suture anchor loop, Size 2/0 green ETHIBOND braided polyester suture utility loop.
Catalog Number
212739
Brand Name
BIOKNOTLESS PANACRYL ETHIBOND
Version/Model Number
212739
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
-
Product Code
JDR
Product Code Name
STAPLE, FIXATION, BONE
Public Device Record Key
8d9309be-60bf-457c-aab8-f9d2a5371db2
Public Version Date
January 28, 2021
Public Version Number
6
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 |