Wedge
GUDID 10871321001918
Labtician Ophthalmics, Inc
Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable 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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