ELIMINATOR
- Primary DI
- 20653405050916
- Brand
- ELIMINATOR
- Company
- Conmed Corporation
- Model
- 000348
- Catalog number
- 000348
- Device description
- CONMED ELIMINATOR PET BILIARY BALLOON DILATOR, 6 MM X 2 CM
- Published
- 2018-07-02
- 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 | 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 |
|---|---|
| K920361 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20653405050916 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20653405050916 | 20653405050916 |
GMDN Terms#
| Term | Definition |
|---|---|
| Stone/foreign-body extraction set | A collection of surgical instruments intended to remove calculi, debris, and/or to retrieve fragments of catheter tubing, wire guides, pull wires, plastic stents and other foreign bodies during urological and/or gastroenterological interventions. It typically consists of a retrieval basket and/or grasping forceps, an introducing sheath or sleeve, and possibly a guidewire; the exact design of the set will vary depending on the surgical method. This is a reusable 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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