Disposable Sure-Flex Biliary Balloon Dilatation Catheter
- Primary DI
- 00813353010103
- Brand
- Disposable Sure-Flex Biliary Balloon Dilatation Catheter
- Company
- Telemed Systems
- Model
- 1346
- Device description
- Biliary Dilator10mm Diameter x 8cm Length Balloon Dimension180cm Total Catheter Length
- Published
- 2023-07-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K901432 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00813353010103 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00813353010103 | 00813353010103 | 813353010103 | 0813353010103 |
GMDN Terms#
| Term | Definition |
|---|---|
| Gastrointestinal/biliary dilation balloon catheter | A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 017939239
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00813353010080 | Disposable Sure-Flex Biliary Balloon Dilatation Catheter | 1342 | 2023-07-12 | |
| 00813353010097 | Disposable Sure-Flex Biliary Balloon Dilatation Catheter | 1344 | 2023-07-12 | |
| 00813353010110 | Disposable Progressive Pressure Dilators | 1415 | 2023-07-12 | |
| 00813353010127 | Disposable Progressive Pressure Dilators | 1418 | 2023-07-12 | |
| 00813353010196 | Disposable Sclerotherapy Needle | 2002 | 2023-08-24 | |
| 00813353010202 | Disposable Sclerotherapy Needle | 2004 | 2023-08-24 | |
| 00813353010219 | Disposable Sclerotherapy Needle | 2006 | 2023-08-24 | |
| 00813353010226 | Disposable Sclerotherapy Needle | 2008 | 2023-08-24 | |
| 00813353010233 | Disposable Sclerotherapy Needle | 2010 | 2023-08-24 | |
| 00813353010240 | Disposable Sclerotherapy Needle | 2014 | 2023-08-24 | |
| 00813353010257 | Disposable Sclerotherapy Needle | 2015 | 2023-08-24 | |
| 00813353010264 | Disposable Sclerotherapy Needle | 2016 | 2023-08-24 | |
| 00813353010271 | Disposable Sclerotherapy Needle | 2018 | 2023-08-24 | |
| 00813353010288 | Disposable Transbronchial Needle | 2102 | 2023-08-24 | |
| 00813353010295 | Disposable Gastrointestinal Cytology Brush | 3002 | 2023-08-24 | |
| 00813353010301 | Disposable Gastrointestinal Cytology Brush | 3004 | 2023-08-24 | |
| 00813353010318 | Disposable Gastrointestinal Cytology Brush | 3006 | 2023-08-24 | |
| 00813353010325 | Disposable Gastrointestinal Cytology Brush | 3008 | 2023-08-24 | |
| 00813353010332 | Disposable Gastrointestinal Cytology Brush | 3010 | 2023-08-24 | |
| 00813353010349 | Disposable Gastrointestinal Cytology Brush | 3012 | 2023-08-24 |
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