| Primary Device ID | 10860004977312 |
| NIH Device Record Key | d1b895f1-e824-4e35-8d1d-d5471f3c0842 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StitchKit |
| Version Model Number | SK-104 |
| Company DUNS | 079994267 |
| Company Name | ORIGAMI SURGICAL 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 | 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 |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com | |
| Phone | 9737656256 |
| info@origamisurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004977315 [Primary] |
| GS1 | 10860004977312 [Package] Contains: 00860004977315 Package: Box [6 Units] In Commercial Distribution |
| GAP | Suture, Nonabsorbable, Silk |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-05 |
| Device Publish Date | 2023-03-28 |
| 00860088000206 | StitchKit ePTFE Suture Delivery Canister |
| 00860088000237 | StitchKit® PTFE Suture and Needle Management Device |
| 00860004977353 | StitchKit® RHP Suture and Needle Management Device |
| 00860004977346 | StitchKit® RSCP Suture and Needle Management Device |
| 00860004977339 | StitchKit® PR Suture and Needle Management Device |
| 10860004977312 | StitchKit® HE Suture and Needle Management Device |
| 10860004977305 | StitchKit® BA Suture and Needle Management Device |
| 10860004977381 | StitchKit® URO Suture and Needle Management Device |
| 10860004977374 | StitchKit® RNY Suture and Needle Management Device |
| 00860004977322 | StitchKit® EC Suture and Needle Management Device |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STITCHKIT 85662513 4286173 Live/Registered |
Origami Surgical, LLC 2012-06-27 |