Duns Number:109903521
Device Description: BIORAPTOR 2.3 PK SUTURE ANCHOR WITH ONE No.2 PRELOADED BIORAPTOR 2.3 PK SUTURE ANCHOR WITH ONE No.2 PRELOADED ULTRABRAID SUTURE, COBRAID BLACK/WHITE
Catalog Number
72201542
Brand Name
BIORAPTOR
Version/Model Number
72201542
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K071586
Product Code
MBI
Product Code Name
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Public Device Record Key
a7a55b20-8085-4bc8-9475-178bb2899bbd
Public Version Date
October 22, 2020
Public Version Number
7
DI Record Publish Date
August 29, 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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |