Wedge
GUDID 10871321001918
Labtician Ophthalmics, Inc
Scleral buckling device, bioabsorbable| Primary Device ID | 10871321001918 |
| NIH Device Record Key | ec8c2283-466c-4e84-a1c0-b7d0d7341fd2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wedge |
| Version Model Number | S 3021 |
| Company DUNS | 248911026 |
| Company Name | Labtician Ophthalmics, Inc |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 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 | 00871321000778 [Unit of Use] |
| GS1 | 10871321001918 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K875014
FDA Product Code
| HQJ | Implant, Absorbable, (Scleral Buckling Methods) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-01-28 |
| Device Publish Date | 2015-10-09 |
On-Brand Devices [Wedge]
| 18713210001925 | S 3022 |
| 18713210001918 | S 3021 |
| 10871321001925 | S 3022 |
| 10871321001918 | S 3021 |
Trademark Results [Wedge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WEDGE 98617487 not registered Live/Pending |
Vode Lighting LLC 2024-06-25 |
 WEDGE 98411802 not registered Live/Pending |
OneUp Innovations, Inc. 2024-02-20 |
 WEDGE 98235741 not registered Live/Pending |
Wedge Studio Inc. 2023-10-23 |
 WEDGE 98090121 not registered Live/Pending |
WILLO PRODUCTS COMPANY, LLC 2023-07-18 |
 WEDGE 97565453 not registered Live/Pending |
Road Runner Bike Bags and Accessories, Inc. 2022-08-25 |
 WEDGE 97060167 not registered Live/Pending |
MONTAGUE, Kenneth 2021-10-05 |
 WEDGE 90978313 not registered Live/Pending |
WEDGE FINANCIAL, INC. 2021-05-11 |
 WEDGE 90850566 not registered Live/Pending |
Acorn Engineering Company 2021-07-27 |
 WEDGE 90703003 not registered Live/Pending |
WEDGE FINANCIAL, INC. 2021-05-11 |
 WEDGE 90065033 not registered Live/Pending |
Streamlight, Inc. 2020-07-21 |
 WEDGE 88690751 not registered Live/Pending |
Kwan Kee Industrial Limited 2019-11-13 |
 WEDGE 88367623 not registered Live/Pending |
Noble Security Inc. 2019-04-02 |
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