Primary Device ID | B033KS7001 |
NIH Device Record Key | ebf27cb6-f650-43e1-9c24-4d57806ca37e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cosgrove Valve Retractor System |
Version Model Number | KS-7001 |
Catalog Number | KS-7001 |
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 | true |
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 | B033KS7001 [Primary] |
GAD | Retractor |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B033KS7001]
Moist Heat or Steam Sterilization
[B033KS7001]
Moist Heat or Steam Sterilization
[B033KS7001]
Moist Heat or Steam Sterilization
[B033KS7001]
Moist Heat or Steam Sterilization
[B033KS7001]
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 |