Fusion FS-OMNI-AWG2-35-205
GUDID 10827002573014
Fusion Omni Pre-Loaded With Acrobat 2 Wire Guide
COOK INCORPORATED
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use| Primary Device ID | 10827002573014 |
| NIH Device Record Key | 3c43886a-602e-41c2-9e07-26ecd5fcf7ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fusion |
| Version Model Number | G57301 |
| Catalog Number | FS-OMNI-AWG2-35-205 |
| Company DUNS | 079720472 |
| Company Name | COOK INCORPORATED |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10827002573014 [Primary] |
FDA Product Code
| KNS | Unit, electrosurgical, endoscopic (with or without accessories) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-07 |
| Device Publish Date | 2020-09-29 |
On-Brand Devices [Fusion]
| 00827002561038 | Fusion Omni-tome Preloaded Sphincterotome |
| 00827002558151 | Fusion Omni-tome Preloaded Sphincterotome |
| 00827002558144 | Fusion Omni-tome Preloaded Sphincterotome |
| 00827002509771 | Fusion Looptip Wire Guide |
| 00827002509764 | Fusion Looptip Wire Guide |
| 00827002509757 | Fusion Looptip Wire Guide |
| 00827002495739 | Fusion Biliary Dilation Catheter |
| 00827002495722 | Fusion Biliary Dilation Catheter |
| 00827002495715 | Fusion Biliary Dilation Catheter |
| 00827002490918 | Fusion Cytology Brush |
| 00827002486768 | Fusion Preloaded Omni-tome |
| 00827002486751 | Fusion Omni-tome |
| 00827002482784 | Fusion Lithotripsy Extraction Basket |
| 00827002482777 | Fusion Lithotripsy Extraction Basket |
| 00827002319110 | Fusion Preloaded Omni-tome |
| 00827002319103 | Fusion Ultra Short Wire Guide |
| 00827002319059 | Fusion Wire Guided Extraction Basket |
| 00827002319035 | Fusion Omni-tome Sphincterotome |
| 10827002315409 | Fusion Wire Guide Locking Device |
| 00827002315396 | Fusion Triple Lumen Needle Knife |
| 00827002315389 | Fusion Extraction Balloon with Multiple Sizing |
| 00827002315372 | Fusion Extraction Balloon with Multiple Sizing |
| 00827002315334 | Fusion Triple Lumen Sphincterotome |
| 00827002315327 | Fusion Biliary Dilation Balloon |
| 00827002315310 | Fusion Biliary Dilation Balloon |
| 00827002315303 | Fusion Biliary Dilation Balloon |
| 00827002315297 | Fusion Biliary Dilation Balloon |
| 00827002315259 | Fusion Cytology Brush |
| 10827002315225 | Fusion Wire Guide Locking Device |
| 00827002267268 | Fusion Ultra Short Wire Guide |
| 10827002573038 | Fusion Omni Pre-Loaded With Acrobat 2 Wire Guide |
| 10827002573014 | Fusion Omni Pre-Loaded With Acrobat 2 Wire Guide |
| 10827002347110 | Fusion Omni Preloaded with Acrobat Wire Guide |
| 10827002346939 | Fusion Omni Preloaded with Acrobat Wire Guide |
| 10827002346014 | Fusion Omni Preloaded with Acrobat Wire Guide |
Trademark Results [Fusion]
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