FDA.reportPublic FDA data

WIDE-EYE Polyptrap

Primary DI
05060423410553
Brand
WIDE-EYE Polyptrap
Company
BODDINGTONS PLASTICS LIMITED
Model
APT013
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
Published
2018-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
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
05060423410546PackageGS150In Commercial Distribution
05060423410553PackageGS156In Commercial Distribution
05060423410591PackageGS125In Commercial Distribution
05060423410539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060423410546050604234105465060423410546
05060423410553050604234105535060423410553
05060423410591050604234105915060423410591
05060423410539050604234105395060423410539

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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Primary DI, Brand, Company table
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00616784802039LabChoice Specimen Bags, 6" x 9" (15.2 cm x 22.9 cm), 1.8 mil, Non-SterileDynarex CorporationNNI2025-03-28
00840117333413LabChoice Specimen Bags, 12" x 15" (30.5 cm x 38.1 cm), 1.8 milDynarex CorporationNNI2025-03-28