FDA UDI
In Commercial Distribution
🇺🇸 United States
WallFlex™ Biliary Transhepatic
DI: 08714729820550
·
Model: M00574660
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WallFlex™ Biliary Transhepatic
- Primary DI
- 08714729820550
- Version / Model
- M00574660
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4cfec534-d12d-4128-a872-cc3e6b2a0937
Device Description
Stent System
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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FGE | CATHETER, BILIARY, DIAGNOSTIC | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43697 | Ophthalmic cryosurgical system control unit | A mains electricity-powered (AC-powered) component of an electronic ophthalmic cryosurgical system designed for the electronic control of the cryogen contained in a connected cylinder through to a connected dedicated cryogen-cooled hand-held applicator (probe). This device will typically include a user control panel that displays user information such as ?ready to use?, ?elapsed time?, ?gas pressure status? and ?applicator tip freezing indicator?. It may provide a microprocessor automated user set-up, perform electronically controlled repetitive freeze and defrost cycles. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729820550 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10 mm Diameter | ||
| Device Size Text, specify | 40 mm Length |