Duns Number:190572854
Device Description: RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 12 Degrees Absorbable - PLA/PDS with Size 2/0 (3 met RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 12 Degrees Absorbable - PLA/PDS with Size 2/0 (3 metric) PANACRYL braided absorbable suture, and 12 Degrees curved needle
Catalog Number
228311
Brand Name
RAPIDLOC PDS PANACRYL
Version/Model Number
228311
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
K023388
Product Code
JDR
Product Code Name
STAPLE, FIXATION, BONE
Public Device Record Key
bf261aa0-15f3-41fd-b804-9401a2128e8d
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 |