Duns Number:216745893
Device Description: The WIDE-EYE Polyp Trap family is designed to attach to the suction port of an endoscope a The WIDE-EYE Polyp Trap family is designed to attach to the suction port of an endoscope and capture excised material by applying suction through the biopsy channel of the endoscope. The product is used as a specimen transport container.
Catalog Number
-
Brand Name
WIDE-EYE Polyptrap
Version/Model Number
APT005
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
NNI
Product Code Name
Container, Specimen, Non-Sterile
Public Device Record Key
2e17bcb9-984d-4f16-b3c8-99e11a796f9f
Public Version Date
July 22, 2021
Public Version Number
5
DI Record Publish Date
November 15, 2016
Package DI Number
5060423410379
Quantity per Package
50
Contains DI Package
05060423410362
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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. | 8 |