FDA.reportPublic FDA data

Disposable surgical irrigation/aspiration system

Definition
A sterile device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an integral battery-powered pump and irrigation/suction controls, a single-use battery pack, tubing, and detachable tips (applicators) of various shapes and sizes for specific surgical applications. This is a single-use device.
GUDID devices
102
Last updated
2020-11-04 09:15:58

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06972130470449SmartPulseApex (Suzhou) Medical Products Company201-03-002020-10-27
06972130470456SmartPulseApex (Suzhou) Medical Products Company201-04-002020-10-27
16972130470149MICROAIRE®Apex (Suzhou) Medical Products Company201-04-002020-10-27
16972130470439AWIApex (Suzhou) Medical Products Company209-002020-10-27
16972130470446SmartPulseApex (Suzhou) Medical Products Company201-03-002020-10-27
16972130470453SmartPulseApex (Suzhou) Medical Products Company201-04-002020-10-27
26972130470436AWIApex (Suzhou) Medical Products Company209-002020-10-27
06972130470142MICROAIRE®Apex (Suzhou) Medical Products Company201-04-002020-08-24
16972130470132MICROAIRE®Apex (Suzhou) Medical Products Company201-03-002020-08-24
B674PS022Perilav Pulsatile IrrigatorStiehl Tech, LLCPS0222020-07-15
00889024380004PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-420-002016-06-01
00889024380011PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-420-012016-06-01
00889024380035PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-475-002016-06-01
00889024380042PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-475-012016-06-01
00889024380066PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-482-002016-06-01
00889024380073PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-482-012016-06-01
00889024380097PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-495-002016-08-12
00889024380103PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-495-012016-06-01
00889024380127PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-920-002016-06-01
00889024380134PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-975-002016-06-01
00889024380141PULSAVAC®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-5150-995-002016-06-01
06957277200692AWIApex (Guangzhou) Tools & Orthopedics Co.209-032020-03-03
06972130470012iTool® APEXPULSE™Apex (Suzhou) Medical Products Company201-02-002020-02-12
06972130470029iTool® APEXPULSE™Apex (Suzhou) Medical Products Company201-03-002020-02-12
34546540144219InterPulseSTRYKER CORPORATION02101000002016-09-23
34546540144233InterPulseSTRYKER CORPORATION02101120002016-09-23
34546540144257InterPulseSTRYKER CORPORATION02101180002016-09-23
34546540144264InterPulseSTRYKER CORPORATION02102000002016-09-23
34546540144288InterPulseSTRYKER CORPORATION02102120002016-09-23
34546540144301InterPulseSTRYKER CORPORATION02102180002016-09-23
34546540144332InterPulseSTRYKER CORPORATION02111000002016-09-23
34546540144349InterPulseSTRYKER CORPORATION02111100002016-09-23
34546540144356InterPulseSTRYKER CORPORATION02111120002016-09-23
34546540144363InterPulseSTRYKER CORPORATION02111140002016-09-23
34546540144370InterPulseSTRYKER CORPORATION02111180002016-09-23
34546540144417InterPulseSTRYKER CORPORATION02112140002016-09-23
34546540184536SurgiLavSTRYKER CORPORATION02070500002016-09-23
34546540184598SurgiLavSTRYKER CORPORATION02075530002016-09-23
34546540184604SurgiLavSTRYKER CORPORATION02075550002016-09-23
34546540184611SurgiLavSTRYKER CORPORATION02075580002016-09-23
34546540184635SurgiLavSTRYKER CORPORATION02075590002016-09-23
34546540184666SurgiLavSTRYKER CORPORATION02075600002016-09-23
34546540673566InterPulseSTRYKER CORPORATION02101140002016-09-23
34546540683831InterPulseSTRYKER CORPORATION02101100002016-09-23
34546540683855InterPulseSTRYKER CORPORATION02112120002016-09-23
34546540859755SurgiLav PlusSTRYKER CORPORATION0207050000E2016-09-23
34546540860515SurgiLavSTRYKER CORPORATION02075610002016-09-23
34546540860577SurgiLavSTRYKER CORPORATION02075640002016-09-23
34546540860638SurgiLavSTRYKER CORPORATION02075800002016-09-23
34546540860652SurgiLavSTRYKER CORPORATION02075830002016-09-23
34546540860690SurgiLavSTRYKER CORPORATION02075860002016-09-23
34546540860713SurgiLavSTRYKER CORPORATION02075890002016-09-23
34546540860737SurgiLavSTRYKER CORPORATION02075900002016-09-23
34546540861567InterPulseSTRYKER CORPORATION0210100000E2016-09-23
34546540861611InterPulseSTRYKER CORPORATION0210110000E2016-09-23
34546540861642InterPulseSTRYKER CORPORATION02101101002016-09-23
34546540861697InterPulseSTRYKER CORPORATION0210112000E2016-09-23
34546540861741InterPulseSTRYKER CORPORATION0210114000E2016-09-23
34546540861765InterPulseSTRYKER CORPORATION02101141002016-09-23
34546540861796InterPulseSTRYKER CORPORATION02101181002016-09-23
34546540861819InterPulseSTRYKER CORPORATION02101182002016-09-23
34546540861833InterPulseSTRYKER CORPORATION02101650002016-09-23
34546540861857InterPulseSTRYKER CORPORATION02101660002016-09-23
34546540861871InterPulseSTRYKER CORPORATION02101670002016-09-23
34546540861956InterPulseSTRYKER CORPORATION0210210000E2016-09-23
34546540862052InterPulseSTRYKER CORPORATION02102181002016-09-23
34546540862205InterPulseSTRYKER CORPORATION02109000002016-09-23
34546540862533InterPulseSTRYKER CORPORATION0211100000E2016-09-23
34546540862564InterPulseSTRYKER CORPORATION0211110000E2016-09-23
06957277200074itool® ApexPulse™Apex (Guangzhou) Tools & Orthopedics Co.201-02-002016-09-23
06957277200081itool® ApexPulse™Apex (Guangzhou) Tools & Orthopedics Co.201-03-002016-09-23
06957277200098itool® ApexPulse™Apex (Guangzhou) Tools & Orthopedics Co.201-04-002016-09-23
06957277200104itool® ApexPulse™Apex (Guangzhou) Tools & Orthopedics Co.201-05-002016-09-23
06957277200180MicroPort®Apex (Guangzhou) Tools & Orthopedics Co.20103002016-09-23
06957277200197MicroPort®Apex (Guangzhou) Tools & Orthopedics Co.20104002016-09-23
37613153097946NASTRYKER CORPORATION0210100000S42016-09-23
37613154054085InterPulseSTRYKER CORPORATION0210114100S12016-09-23
37613154076865InterPulseSTRYKER CORPORATION0210114000S52016-09-23
37613154547259InterPulseSTRYKER CORPORATION02109181002016-09-23
37613154730217InterPulseSTRYKER CORPORATION02109180002016-09-23