Lacrimedics
GUDID 00856611008016
Summit Medical, Inc.
Lacrimal punctum plug| Primary Device ID | 00856611008016 |
| NIH Device Record Key | 22a75ae1-02f7-479d-8b91-4ccbdc468bbe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lacrimedics |
| Version Model Number | 1639 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856611008016 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030300
FDA Product Code
| LZU | Plug, Punctum |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-31 |
| Device Publish Date | 2023-03-23 |
On-Brand Devices [Lacrimedics]
| 00856611008016 | 1639 |
| 00856611008009 | 1638 |
Trademark Results [Lacrimedics]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LACRIMEDICS 87047366 5114376 Live/Registered |
LACRIMEDICS, INC. 2016-05-23 |
 LACRIMEDICS 74586095 1940829 Dead/Cancelled |
LACRIMEDICS, INC. 1994-10-07 |
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