Instrusafe
GUDID 00385640027144
SUMMIT MEDICAL, INC.
Tympanostomy tube| Primary Device ID | 00385640027144 |
| NIH Device Record Key | a7dee0a0-9ab0-44f3-a441-23029bb1f2dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Instrusafe |
| Version Model Number | SM-45214 |
| Company DUNS | 965484699 |
| Company Name | SUMMIT MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640027144 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K830228
FDA Product Code
| ETD | Tube, Tympanostomy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-15 |
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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