Duns Number:178074951
Device Description: Monarc Needle Passers
Catalog Number
1006229
Brand Name
Monarc
Version/Model Number
1006229
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2016
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
OTN
Product Code Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Public Device Record Key
8ff5a424-2f8c-46f3-968f-417b635d5111
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 24, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| 3 | A medical device with high risk that requires premarket approval | 2 |