Combo Pack
GUDID 10871321002304
Combo Pack
Labtician Ophthalmics, Inc
Scleral buckling device, bioabsorbable| Primary Device ID | 10871321002304 |
| NIH Device Record Key | e69ad1b8-abe4-4071-8886-ae1e8a732f0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Combo Pack |
| Version Model Number | S 6983 |
| 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 | 00871321002291 [Unit of Use] |
| GS1 | 10871321002304 [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 | 5 |
| Public Version Date | 2021-01-28 |
| Device Publish Date | 2018-02-22 |
On-Brand Devices [Combo Pack]
| 18713210002595 | Combo Pack |
| 18713210002571 | Combo Pack |
| 18713210002304 | Combo Pack |
| 18713210002106 | Combo Pack |
| 18713210002090 | Combo Pack |
| 18713210002069 | Combo Pack |
| 10871321002595 | Combo Pack |
| 10871321002571 | Combo Pack |
| 10871321002304 | Combo Pack |
| 10871321002106 | Combo Pack |
| 10871321002090 | Combo Pack |
| 10871321002069 | Combo Pack |
Trademark Results [Combo Pack]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COMBO PACK 78248710 3006422 Dead/Cancelled |
IDEAL Industries, Inc. 2003-05-12 |
 COMBO PACK 75131009 2135313 Dead/Cancelled |
MACRO ENGINEERING & TECHNOLOGY INC. 1996-07-08 |
 COMBO PACK 74273205 1748355 Dead/Cancelled |
PURE FILL CORPORATION 1992-05-05 |
 COMBO PACK 73569063 1401012 Dead/Cancelled |
CAROUSEL INDUSTRIES, INC. 1985-11-18 |
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