CoLink® PCR Plating System
GUDID 00810021864556
CoLink® PCR MTP Plate NX, Narrow, 0° DF, 6-Hole, Left
IN2BONES USA, LLC
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile| Primary Device ID | 00810021864556 |
| NIH Device Record Key | bf72fb7f-0f49-420b-975e-d60960b2b22b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoLink® PCR Plating System |
| Version Model Number | P40 SP238 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 00810021864556 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213698
FDA Product Code
| HRS | Plate, Fixation, Bone |
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 | 2022-07-06 |
| Device Publish Date | 2022-06-28 |
On-Brand Devices [CoLink® PCR Plating System]
| 00810021864556 | CoLink® PCR MTP Plate NX, Narrow, 0° DF, 6-Hole, Left |
| 00810021864549 | CoLink® PCR MTP Plate NX, Narrow, 0° DF, 6-Hole, Right |
| 00810021864532 | CoLink® PCR MTP Plate NX Narrow, 4° DF, 6-Hole, Left |
| 00810021864525 | CoLink® PCR MTP Plate NX Narrow, 4° DF, 6-Hole, Right |
| 00810021864518 | CoLink® PCR Universal Plate, 6-hole |
| 00810021864501 | CoLink® PCR Universal Plate, 5-hole |
| 00810021864495 | CoLink® PCR Universal Plate, 4-hole |
| 00810021864488 | CoLink® PCR Universal Plate, 3-hole |
| 00810021864471 | CoLink® PCR Universal Plate, 2-hole |
Trademark Results [CoLink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COLINK 86871790 5297174 Live/Registered |
In2Bones USA, LLC 2016-01-11 |
 COLINK 86141742 4635851 Live/Registered |
Colink Digital Technology Co., Ltd 2013-12-12 |
 COLINK 75453954 2287337 Live/Registered |
CoBank, ACB 1998-03-20 |
 COLINK 75331848 2183998 Dead/Cancelled |
Continental Link, Inc. 1997-07-28 |
 COLINK 74582317 not registered Dead/Abandoned |
Chevron Chemical Company 1994-09-30 |
 COLINK 74217580 not registered Dead/Abandoned |
Chevron Chemical Company 1991-10-28 |
 COLINK 73702298 1501129 Dead/Cancelled |
INLEX, INC. 1987-12-21 |
 COLINK 73702297 not registered Dead/Abandoned |
INLEX, INC. 1987-12-21 |
 COLINK 73702296 1530826 Dead/Cancelled |
INLEX, INC. 1987-12-21 |
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