Duns Number:021717889
Device Description: Transobturator Sling System with PrecisionBlue™ Design
Catalog Number
-
Brand Name
Obtryx™ II System - Halo
Version/Model Number
M0068505110
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
-
Product Code
OTN
Product Code Name
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Public Device Record Key
e9175619-f35e-4e94-8793-e47c33577125
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2015
Package DI Number
08714729839279
Quantity per Package
5
Contains DI Package
08714729837565
Package Discontinue Date
April 07, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |