INSTRUSAFE
GUDID 10385640066577
Summit Medical, Inc.
Instrument tray, reusable| Primary Device ID | 10385640066577 |
| NIH Device Record Key | 13a001bc-1a95-45fe-ac73-6395d9f50588 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INSTRUSAFE |
| Version Model Number | OM-1001-MU (ST-SS1) |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640066570 [Primary] |
| GS1 | 10385640066577 [Package] Contains: 00385640066570 Package: Box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051157
FDA Product Code
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-27 |
| Device Publish Date | 2021-09-17 |
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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