| Primary Device ID | 00385640039611 |
| NIH Device Record Key | 23969c68-67e1-4cb0-a082-750a62c6c5e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | V-49052 |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640039611 [Primary] |
| ETD | Tube, Tympanostomy |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00385640039611]
Ethylene Oxide
[00385640039611]
Ethylene Oxide
[00385640039611]
Ethylene Oxide
[00385640039611]
Ethylene Oxide
[00385640039611]
Ethylene Oxide
[00385640039611]
Ethylene Oxide
[00385640039611]
Ethylene Oxide
[00385640039611]
Ethylene Oxide
[00385640039611]
Ethylene Oxide
[00385640039611]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2018-10-10 |