FDA UDI
In Commercial Distribution
🇺🇸 United States
WIDE-EYE Polyptrap
DI: 05060423410539
·
Model: APT013
·
BODDINGTONS PLASTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- WIDE-EYE Polyptrap
- Primary DI
- 05060423410539
- Version / Model
- APT013
- Company Name
- BODDINGTONS PLASTICS LIMITED
- Labeler DUNS
- 216745893
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-16
- Public Version
- 5
- Public Version Date
- 2024-02-21
- Public Version Status
- Update
- Public Device Record Key
- e5b3c93e-c3ab-4561-b773-1642b5ef3dfc
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NNI | Container, Specimen, Non-Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060423410553 | GS1 | Pallet | 56 | In Commercial Distribution | |
| Package | 05060423410546 | GS1 | Shipper | 50 | In Commercial Distribution | |
| Package | 05060423410591 | GS1 | Carton | 25 | In Commercial Distribution | |
| Primary | 05060423410539 | GS1 |