AccessGUDID - DEVICE: WIDE-EYE Polyptrap (05060423410539)

GUDID

Device Identifier (DI) Information

Brand Name: WIDE-EYE Polyptrap
Version or Model: APT013
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BODDINGTONS PLASTICS LIMITED

Primary DI Number: 05060423410539
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216745893 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47775	General specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNI	Container, Specimen, Non-Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e5b3c93e-c3ab-4561-b773-1642b5ef3dfc
Public Version Date: February 21, 2024
Public Version Number: 5
DI Record Publish Date: October 16, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05060423410553	56	05060423410546	In Commercial Distribution	Pallet
05060423410546	50	05060423410591	In Commercial Distribution	Shipper
05060423410591	25	05060423410539	In Commercial Distribution	Carton