ELIMINATOR
- Primary DI
- 00653405050919
- Brand
- ELIMINATOR
- Company
- Conmed Corporation
- Model
- 000348
- Catalog number
- 000348
- Device description
- 6MM X 2CM PET BILIARY BALLOON DILATOR
- Published
- 2015-10-24
- Public version status
- Update
- Distribution status
- Not 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 |
|---|---|
| K920361 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00653405050919 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00653405050919 | 00653405050919 | 653405050919 | 0653405050919 |
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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
| Length | 2 | Centimeter |
| Outer Diameter | 6 | Millimeter |
| Pressure | 150 | Pound per Square Inch |
Sterilization Methods#
| Method |
|---|
| Ethylene Oxide |
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
- Sterilization required before use
- true
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