DURAGLIDE 007124
GUDID 00653405053715
DURAGLIDE STONE BALLOON 11.5MM, ABOVE
Conmed Corporation
Biliary stone retrieval balloon catheter| Primary Device ID | 00653405053715 |
| NIH Device Record Key | 62be3c31-b33a-4da9-aa06-195ebb58aed3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DURAGLIDE |
| Version Model Number | 007124 |
| Catalog Number | 007124 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
| Outer Diameter | 11.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653405053715 [Primary] |
| GS1 | 20653405053719 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993892
FDA Product Code
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
[00653405053715]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [DURAGLIDE]
| 00653405053753 | DURAGLIDE STONE BALLOON 15MM, BELOW |
| 00653405053746 | DURAGLIDE STONE BALLOON 11.5MM, BELOW |
| 00653405053739 | DURAGLIDE STONE BALLOON 8.5MM, BELOW |
| 00653405053722 | DURAGLIDE STONE BALLOON 15MM, ABOVE |
| 00653405053715 | DURAGLIDE STONE BALLOON 11.5MM, ABOVE |
| 00653405053708 | DURAGLIDE STONE BALLOON 8.5MM, ABOVE |
| 20653405053801 | DURAGLIDE Stone Balloon, 15.0mm, 7-5f |
| 20653405053795 | DURAGLIDE Stone Balloon, 11.5mm, 7-5f |
| 20653405053788 | DURAGLIDE Stone Balloon, 8.5mm, 7-5f |
| 20653405053771 | DURAGLIDE Stone Balloon, 15.0mm, 7f |
| 20653405053764 | DURAGLIDE Stone Balloon, 11.5mm, 7f |
| 20653405053757 | STONE BLN 3L,15MM BELOW |
| 20653405053733 | STONE BLN 3L,8.5MM,BELOW |
Trademark Results [DURAGLIDE]
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