NovoStitch
GUDID 00853541006105
NovoStitch Meniscal Repair Cartridge
Ceterix Orthopaedics
Polyolefin suture, multifilament| Primary Device ID | 00853541006105 |
| NIH Device Record Key | a43c645a-43cc-4068-a8e9-66bfe246f8b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovoStitch |
| Version Model Number | CTX-R001 |
| Company DUNS | 054774944 |
| Company Name | Ceterix Orthopaedics |
| 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 | 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
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | 1-650-241-1748 |
| info@ceterix.com | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853541006105 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063778
FDA Product Code
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2018-05-07 |
On-Brand Devices [NovoStitch]
| 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) |
Trademark Results [NovoStitch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVOSTITCH 85900717 4548945 Live/Registered |
CETERIX ORTHOPAEDICS, INC. 2013-04-10 |
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