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
APT013U
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
NNI
Product Code Name
Container, Specimen, Non-Sterile
Public Device Record Key
621450f1-ca5f-4e7e-9f94-77c8256954b4
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
October 16, 2018
Package DI Number
05060423410584
Quantity per Package
56
Contains DI Package
05060423410577
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
| 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 |