FIT
- Primary DI
- 10653405006411
- Brand
- FIT
- Company
- Conmed Corporation
- Model
- F922LW
- Catalog number
- F922LW
- Device description
- FIT Biliary Stone Balloon Long Wire
- Published
- 2017-05-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
conmed.comProduct Codes#
| Code | Name |
|---|---|
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K131642 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10653405006411 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10653405006411 | 10653405006411 |
GMDN Terms#
| Term | Definition |
|---|---|
| Biliary stone retrieval balloon catheter | A flexible, tubular, manual endotherapy device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) in the biliary tract. It is inserted through the working channel of an endoscope, typically beyond the stones where the balloon is inflated and retracted, the balloon pushing the trapped stones before it out of the biliary tract. It typically has more than one lumen to allow,.e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Outer Diameter | 0.035 | Inch |
| Outer Diameter | 0.89 | Millimeter |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)237-0169 | CUSTOMER_SERVICE@CONMED.COM |
Regulatory Flags#
- DUNS number
- 071595540
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
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| 10845854032619 | CROSSFT | TFT-45M | TFT-45M | 2021-01-19 |
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| 10845854032657 | CROSSFT | TFT-65M | TFT-65M | 2021-01-19 |
| 10653405004646 | ELECTROLASE HYFRECATOR | 7-100-8BX | 7-100-8BX | 2016-09-24 |
| 10653405013785 | THERMOGARD | 7-384 | 7-384 | 2016-09-24 |
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