StitchKit
GUDID 00860004977346
StitchKit® RSCP Suture and Needle Management Device
ORIGAMI SURGICAL LLC
Polyester suture, bioabsorbable, monofilament, non-antimicrobial| Primary Device ID | 00860004977346 |
| NIH Device Record Key | c79c166e-7bad-4319-ba07-eba7e82af9ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StitchKit |
| Version Model Number | SK-106 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004977346 [Primary] |
| GS1 | 10860004977343 [Package] Package: Box [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211792
FDA Product Code
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
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 | 2023-04-05 |
| Device Publish Date | 2023-03-28 |
On-Brand Devices [StitchKit]
| 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 |
Trademark Results [StitchKit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STITCHKIT 85662513 4286173 Live/Registered |
Origami Surgical, LLC 2012-06-27 |
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