StitchKit
GUDID 00860088000237
StitchKit® PTFE Suture and Needle Management Device
ORIGAMI SURGICAL LLC
Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament| Primary Device ID | 00860088000237 |
| NIH Device Record Key | 71f35a4c-8569-4915-87eb-64f336183ad9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StitchKit |
| Version Model Number | VH-PC |
| 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 | 00860088000237 [Primary] |
| GS1 | 10860088000234 [Package] Package: Box [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123811
FDA Product Code
| NAY | System,Surgical,Computer Controlled Instrument |
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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