Duns Number:318130267
Device Description: Orbit-Snare, Rotatable Polypectomy Snare Oval, Loop Diameter 15 mm, Catheter Diameter 2.5 Orbit-Snare, Rotatable Polypectomy Snare Oval, Loop Diameter 15 mm, Catheter Diameter 2.5 mm, Sheath Length 230 cm
Catalog Number
01-15-230
Brand Name
Orbit-Snare
Version/Model Number
01-15-230
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
FDI
Product Code Name
Snare, Flexible
Public Device Record Key
2c4d2ec5-8e5d-4f71-b505-3fef60f4771b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
4052838015394
Quantity per Package
10
Contains DI Package
04052838015387
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |