Duns Number:071595540
Device Description: CONTOUR MENISCUS ARROW 1.1MM X 10MM,3/EA
Catalog Number
541110-3
Brand Name
CONTOUR MENISCUS ARROW
Version/Model Number
541110-3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 06, 2022
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
MAI
Product Code Name
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Public Device Record Key
6c16e31c-f5b3-493a-b39f-aaec1555ba7a
Public Version Date
June 07, 2022
Public Version Number
4
DI Record Publish Date
October 24, 2015
Package DI Number
20845854017149
Quantity per Package
3
Contains DI Package
10845854017142
Package Discontinue Date
June 06, 2022
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |