FDA UDI
In Commercial Distribution
🇺🇸 United States
Trapezoid RX
DI: 08714729296393
·
Model: M00510880
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trapezoid RX
- Primary DI
- 08714729296393
- Version / Model
- M00510880
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2021-01-06
- Public Version Status
- Update
- Public Device Record Key
- a067dc5d-9350-4a0b-a9c9-5e0d7c4a0e0e
Device Description
Wireguided Retrieval Basket
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LQC | Lithotriptor, biliary mechanical | Gastroenterology, Urology | 876.4500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64354 | Manual biliary stone fragmenter | A manual instrument designed to be inserted through the working channel of an endoscope to trap and fragment/crush biliary stones in situ for the treatment of conditions such as cholelithiasis. It typically consists of a flexible sheath with a braided self-expanding grasping mechanism at the distal end, which has the ability to contract around and fragment stones; it may incorporate a handle and/or be attached to an independent handle. The device is typically used in association with procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic cholecystectomy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729296393 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2.5 cm Diameter |