Instrusafe
GUDID 00385640002424
SUMMIT MEDICAL, INC.
Middle ear decompressor, positive pressure| Primary Device ID | 00385640002424 |
| NIH Device Record Key | d6587734-53cb-4667-9824-d6cf96f42b03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Instrusafe |
| Version Model Number | EP-1000 |
| Company DUNS | 965484699 |
| Company Name | SUMMIT MEDICAL, INC. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640002424 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073401
FDA Product Code
| MJV | Device, Inflation, Middle Ear |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-11 |
On-Brand Devices [Instrusafe]
Trademark Results [Instrusafe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSTRUSAFE 85717324 4309161 Live/Registered |
Summit Medical, Inc. 2012-08-30 |
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