Home GUDID 30845854041103 10K
Primary DI 30845854041103
Brand 10K
Company Conmed Corporation
Model 10K
Catalog number 10K
Device description IRRIGATION CONSOLE 10K
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES HRX Arthroscope
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2 HRX Arthroscope Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30845854041103 Direct Marking GS1 0 10845854041109 Primary GS1 0 20845854041106 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30845854041103 30845854041103 10845854041109 10845854041109 20845854041106 20845854041106
GMDN Terms# Term, Definition table Term Definition Arthroscopic irrigation/insufflation system A mains electricity (AC-powered) device assembly designed to provide controlled distention and irrigation (expansion by pressure and continual flushing) of the tissue and space around a joint where arthroscopy is being performed (e.g., the knee or shoulder joint). This is achieved by filling the cavity with a sterile fluid that is pumped into the wound by the system's pump(s) and distends the tissue around the site to improve visualization and enlarge the surgical field. Suction may also be applied by the system to assist in the removal of the surgically-resected bone, cartilage, and other tissue/debris from the site.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 KEEP DRY Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 93 Percent (%) Relative Humidity Storage Environment Temperature -4 Degrees Fahrenheit 158 Degrees Fahrenheit Storage Environment Temperature 20 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 071595540 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198506091292 ELMED INCORPORATED ELMED INCORPORATED GEI 2026-06-09 00198506091308 ELMED INCORPORATED ELMED INCORPORATED GEI 2026-06-09 00198506091360 ELMED INCORPORATED ELMED INCORPORATED GEI 2026-06-09 00198506091377 ELMED INCORPORATED ELMED INCORPORATED GEI 2026-06-09 00198506091384 ELMED INCORPORATED ELMED INCORPORATED GEI 2026-06-09 00198506091391 ELMED INCORPORATED ELMED INCORPORATED GEI 2026-06-09 00860015792006 NOVOCLEAR™ Device Aventix Medical Inc. GEI 2026-06-09 00860015792013 AVENTIX® PFX System Aventix Medical Inc. GEI 2026-06-09 00685447020677 RFP-100A™ RF Puncture Generator BOSTON SCIENTIFIC CORPORATION GEI 2026-06-08 08800042706159 Artisential Monopolar Spatula LIVSMED GEI 2026-06-05 07613327638226 Omnicurve STRYKER CORPORATION HRX 2024-09-03 07613327638240 Omnicurve STRYKER CORPORATION HRX 2024-09-03 07613327638257 Omnicurve STRYKER CORPORATION HRX 2024-09-03 07613327638431 Omnicurve STRYKER CORPORATION HRX 2024-09-03 07613327638448 Omnicurve STRYKER CORPORATION HRX 2024-09-03 00887482149584 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149591 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149607 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149614 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149621 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149638 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149645 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149652 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149669 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149676 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149683 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 00887482149690 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2024-08-26 07613327554649 Omnicurve STRYKER CORPORATION HRX 2023-11-02 08800020104304 Density Main body Jeisys Medical Inc. GEI 2023-08-29 07613327413281 Connected OR Hub STRYKER CORPORATION HRX 2023-07-26
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