Duns Number:187502109
Device Description: 4.5MM MAINSTAY ZIP ANCHOR WITH ? CIRCLE CUTTING NEEDLE, 2 STRANDS #2 BRAIDED POLYESTER
Catalog Number
3910-002-245
Brand Name
Mainstay
Version/Model Number
3910-002-245
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 09, 2017
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
K965175
Product Code
JDR
Product Code Name
STAPLE, FIXATION, BONE
Public Device Record Key
60d35bc8-6db5-4b6b-9568-105ff25c7e17
Public Version Date
March 21, 2019
Public Version Number
5
DI Record Publish Date
September 09, 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 | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |