| Primary Device ID | B033KS71019 |
| NIH Device Record Key | 62cba84a-6c7a-43c3-84bb-de1e8794ab44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cosgrove Valve Retractor System |
| Version Model Number | KS-7101-9 |
| Catalog Number | KS-7101-9 |
| Company DUNS | 004171112 |
| Company Name | Kapp Surgical Instrument Co. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (216) 587-4400 |
| info@kappsurgical.com | |
| Phone | (216) 587-4400 |
| info@kappsurgical.com | |
| Phone | (216) 587-4400 |
| info@kappsurgical.com | |
| Phone | (216) 587-4400 |
| info@kappsurgical.com | |
| Phone | (216) 587-4400 |
| info@kappsurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B033KS71019 [Primary] |
| GAD | Retractor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B033KS71019]
Moist Heat or Steam Sterilization
[B033KS71019]
Moist Heat or Steam Sterilization
[B033KS71019]
Moist Heat or Steam Sterilization
[B033KS71019]
Moist Heat or Steam Sterilization
[B033KS71019]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-26 |
| Device Publish Date | 2022-05-18 |
| B033KS70021 | Cosgrove Mitral Valve Retractor attachment only |
| B033KS7000S1 | Cosgrove Mitral Valve Retractor - Small Adult complete with 2 mounting bars |
| B033KS7000L1 | Cosgrove Mitral Valve Retractor - Large Adult complete with 2 mounting bars |
| B033KS7111A1 | Cosgrove Mitral Valve Retractor supplied with Ankeney Sternal Retractor |
| B033KS71072S1 | Cooley Sternum Retractor Small with two mounting bars 40mm x 110mm blade and 200mm arm |
| B033KS71072L1 | Cooley Sternum Retractor Large with two mounting bars 40mm x 110mm blade and 250mm arm |
| B033KS7103S1 | Solid Retractor Blade |
| B033KS7103R1 | Right Angled Small Blade |
| B033KS7103L1 | Left Angled Small Blade |
| B033KS71031 | Small Retractor Blade (standard 6 1/8" handle length) |
| B033KS7101UK1 | Tricuspid Retractor Blade, Unknurled handle |
| B033KS71019 | Tricuspid Retractor Blade (custom 9" handle length) |
| B033KS71018 | Tricuspid Retractor Blade (custom 8" handle length) |
| B033KS710110 | Tricuspid Retractor Blade (custom 10" handle length) |
| B033KS7101 | Tricuspid Retractor Blade (standard) |
| B033KS7001M1 | Cosgrove on Hospital Morse Retractor |
| B033KS7001G1 | Cosgrove Mitral Valve Retractor mounted on hospitals Gerbode Retractor |
| B033KS7001A1 | Cosgrove Mitral Valve Retractor mounted on hospitals Ankeney Sternal retractor |
| B033KS7001 | Cosgrove Mitral Valve Retractor mounted on hospitals own sternal retractor |