SUMMIT MEDICAL SP-78100
GUDID 10385640065228
SUMMIT MEDICAL, INC.
Intranasal splint, non-biodegradable| Primary Device ID | 10385640065228 |
| NIH Device Record Key | ed71f55c-ad45-4d02-b273-c70dfd1434bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUMMIT MEDICAL |
| Version Model Number | SP-78107 |
| Catalog Number | SP-78100 |
| 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640065221 [Primary] |
| GS1 | 10385640065228 [Package] Contains: 00385640065221 Package: Box [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K982667
FDA Product Code
| LFB | Button, Nasal Septal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
[10385640065228]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-28 |
| Device Publish Date | 2021-06-18 |
On-Brand Devices [SUMMIT MEDICAL]
Trademark Results [SUMMIT MEDICAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUMMIT MEDICAL 76311856 3043090 Live/Registered |
SUMMIT MEDICAL LIMITED 2001-09-12 |
 SUMMIT MEDICAL 74676630 2038183 Dead/Cancelled |
Summit Medical Systems, Inc. 1995-05-16 |
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