COR-KNOT® MIS
GUDID 10850200006107
COR-KNOT® MIS DEVICE KIT Base Package Type - Kit Each sterile package kit contains (2) single patient use COR-KNOT® MIS Devices.
LSI Solutions, Inc.
Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable| Primary Device ID | 10850200006107 |
| NIH Device Record Key | b6b568e5-3f5e-4396-a6df-33e409a90196 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COR-KNOT® MIS |
| Version Model Number | 030800 |
| Company DUNS | 603420183 |
| Company Name | LSI Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 Dimensions
| Length | 31 Centimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Outer Diameter | 5 Millimeter |
| Length | 31 Centimeter |
| Length | 31 Centimeter |
| Length | 31 Centimeter |
| Length | 31 Centimeter |
| Length | 31 Centimeter |
| Length | 31 Centimeter |
| Length | 31 Centimeter |
| Length | 31 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850200006100 [Primary] |
| GS1 | 10850200006107 [Package] Contains: 00850200006100 Package: Case [6 Units] In Commercial Distribution |
| GS1 | 40850200006108 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100593
FDA Product Code
| HCF | Instrument, Ligature Passing And Knot Tying |
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 | 2018-07-06 |
| Device Publish Date | 2016-05-12 |
On-Brand Devices [COR-KNOT® MIS]
| 10850200006275 | COR-KNOT® MIS COMBO KIT Base Package Type - Kit Each sterile package kit contains (2) single pa |
| 10850200006107 | COR-KNOT® MIS DEVICE KIT Base Package Type - Kit Each sterile package kit contains (2) single p |
Trademark Results [COR-KNOT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COR-KNOT 85342922 4080219 Live/Registered |
LSI SOLUTIONS, INC. 2011-06-10 |
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