CoLag P06 S0004
GUDID 00810021866086
CoLag Single Use Kit - Dia. 4.0
IN2BONES USA, LLC
General internal orthopaedic fixation system implantation kit| Primary Device ID | 00810021866086 |
| NIH Device Record Key | 0d0a0950-6971-4166-baa6-f869e94d29cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoLag |
| Version Model Number | P06 S0004 |
| Catalog Number | P06 S0004 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| 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 | true |
| 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 | 00810021866086 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170518
FDA Product Code
| LXH | Orthopedic manual surgical instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-01-03 |
| Device Publish Date | 2024-12-10 |
On-Brand Devices [CoLag]
| 00810021866086 | CoLag Single Use Kit - Dia. 4.0 |
| 00810021866079 | CoLag Single Use Kit - Dia. 3.0 |
| 00810021866062 | CoLag Single Use Kit - Dia. 2.0/2.5 |
| 00810021866963 | CoLag 2.0-4.0 Reusable Instrument Set, NS |
| 00810021866956 | CoLag 5.0/6.7 Reusable Instrument Set, NS |
Trademark Results [CoLag]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COLAG 87141101 5325214 Live/Registered |
In2Bones USA, LLC 2016-08-17 |
 COLAG 73589635 1526448 Dead/Cancelled |
STENA DIAGNOSTICS AKTIEBOLAG 1986-03-24 |
 COLAG 72452886 1002292 Dead/Expired |
AMERICAN AIR FILTER COMPANY, INC. 1973-03-29 |
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