Hemospray HEMO-10
GUDID 00827002210493
HEMOSPRAY ENDOSCOPIC HEMOSTAT
COOK INCORPORATED
Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Inorganic haemostatic agent, sterile Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent Non-organic haemostatic agent| Primary Device ID | 00827002210493 |
| NIH Device Record Key | 442ff61c-2459-4cf7-a237-0b3f93b71aed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemospray |
| Version Model Number | G21049 |
| Catalog Number | HEMO-10 |
| 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. |
| 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 | 00827002210493 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN170015
FDA Product Code
| QAU | Hemostatic device for endoscopic gastrointestinal use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-05-25 |
On-Brand Devices [Hemospray]
| 00827002565722 | HEMOSPRAY ENDOSCOPIC HEMOSTAT |
| 00827002210493 | HEMOSPRAY ENDOSCOPIC HEMOSTAT |
Trademark Results [Hemospray]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOSPRAY 85174319 4440539 Live/Registered |
COOK MEDICAL TECHNOLOGIES LLC 2010-11-11 |
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