| Primary Device ID | 00853541006167 |
| NIH Device Record Key | 20c80ae1-8e1f-431c-94f8-3203d71b2dd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovoStitch |
| Version Model Number | CTX-A001 |
| Company DUNS | 054774944 |
| Company Name | Ceterix Orthopaedics |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853541006167 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2018-05-07 |
| 00853541006167 | NovoStitch Disposable Suture Passer |
| 00853541006112 | NovoStitch Pro Meniscal Repair System |
| 00853541006105 | NovoStitch Meniscal Repair Cartridge |
| 00853541006082 | NovoStitch Plus Meniscal Repair System |
| 00853541006068 | NovoStitch Meniscal Repair Cartridge, Size 0 |
| 00853541006051 | NovoStitch Pro Meniscal Repair System, CTX-A004 (Size 0) |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NOVOSTITCH 85900717 4548945 Live/Registered |
CETERIX ORTHOPAEDICS, INC. 2013-04-10 |