FDA.reportPublic FDA data

WIDE-EYE Polyptrap

Primary DI
05060423410362
Brand
WIDE-EYE Polyptrap
Company
BODDINGTONS PLASTICS LIMITED
Model
APT005
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.
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060423410386PackageGS136In Commercial Distribution
5060423410379PackageGS150In Commercial Distribution
05060423410362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060423410386050604234103865060423410386
5060423410379050604234103795060423410379
05060423410362050604234103625060423410362

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive, non-sterileA non-sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
216745893
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060423410164Endocuff VisionARV1102016-08-08
05060423410171Endocuff VisionARV1202016-08-08
05060423410188Endocuff VisionARV1302016-08-09
05060423410195Endocuff VisionARV1402016-08-09
05060423410249Endocuff Vision ARV110U2017-01-20
05060423410256Endocuff VisionARV120U2017-01-20
05060423410263Endocuff VisionARV130U2017-01-23
05060423410270Endocuff VisionARV140U2017-01-23
05060423410089EndocuffAEC1102016-08-08
05060423410096EndocuffAEC1202016-08-08
05060423410102EndocuffAEC1302016-08-08
05060423410119EndocuffAEC1402016-08-08
05060423410324Endocuff Vision ARV110U2017-01-20
05060423410393WIDE-EYE MultitrapAPT0062016-11-15
05060423410539WIDE-EYE PolyptrapAPT0132018-10-16
05060423410560WIDE-EYE PolyptrapAPT013U2018-10-16
05060423410911Non-sterile specimen mailer and storage container PE 50 StandardPE50 Standard2023-05-25
05060423410935Peezy Non-sterile specimen mailer and storage container PE 51 BoricPE 51 Boric2023-05-09
05060423410959Peezy Non-sterile specimen mailer and storage container PE 51 BoricPE 51 Boric2023-05-09
05060423410690Non-sterile specimen mailer and storage container PE 50 Standard PE 50 2023-05-25

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