FDA.reportPublic FDA data

CLEANEST

Primary DI
06951233720170
Brand
CLEANEST
Company
Guangzhou Clean Medical Products Manufacturing Corp.
Model
W-202-P3(EC)
Catalog number
W-202-P3(EC)
Device description
Accessory: Femoral Brush Nozzle (Long Nozzle) (Used for Disposable Electronically Pulsed Lavage Suction Apparatus) (Model No.: W-202, W-203, W-205)
Published
2024-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06951233720170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06951233720170069512337201706951233720170

GMDN Terms#

Term, Definition table
TermDefinition
Disposable surgical irrigation/aspiration systemA 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 electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device.

Regulatory Flags#

DUNS number
529707388
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06951233720644EASYMIX® bowlLD2000LD20002022-12-12
06951233720842PALAGUN®CL006-02E(CM194)50823712025-06-05
06951233721610CLEANESTCL006-06A1-02ECL006-06A1-02E2024-05-15
06951233721634CLEANESTCL006-06A2-01ECL006-06A2-01E2024-05-15
06951233721658CLEANESTCL006-06A2-02ECL006-06A2-02E2024-05-15
06951233721665CLEANESTCL006-06B1-01ECL006-06B1-01E2024-05-15
06951233721672CLEANESTCL006-06B1-02ECL006-06B1-02E2024-05-15
06951233721696CLEANESTCL006-06B2-01ECL006-06B2-01E2024-05-15
06951233721719CLEANESTCL006-06B2-02ECL006-06B2-02E2024-05-15
06951233721726CLEANESTCL006-06C1-01ECL006-06C1-01E2024-05-15
06951233721733CLEANESTCL006-06C1-02ECL006-06C1-02E2024-05-15
06951233721757CLEANESTCL006-06C2-01ECL006-06C2-01E2024-05-15
06951233721771CLEANESTCL006-06C2-02ECL006-06C2-02E2024-05-15
06951233721788CLEANESTCL006-06-17ECL006-06-17E2024-05-15
06951233721795CLEANESTCL006-06-18ECL006-06-18E2024-05-15
06951233721603CLEANESTCL006-06A1-01ECL006-06A1-01E2024-05-13
04260102136038HeraeusCL006-01-18(CM194)50763732024-04-11
06951233720125CLEANESTW-202-B(EC)W-202-B(EC)2024-04-11
06951233720316CLEANESTW-202-P4(EC)W-202-P4(EC)2024-04-11
06951233720330CLEANESTW-202-P11(EC)W-202-P11(EC)2024-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056880636BactisureOSARTIS GmbHFQH2026-08-25
00850022135316VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
00850022135330VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
00850022135347VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
05051471221512De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2026-05-27
B674PL30010PerilavStiehl Tech, LLCFQH2026-05-13
B674T93LF10PerilavStiehl Tech, LLCFQH2026-05-13
07640407460811debritom+Medaxis AGFQH2026-04-17
07649996166302debritom+Medaxis AGFQH2026-04-17
07649996166043debritom+Medaxis AGFQH2026-04-08
00382909101201SurgiphorCAREFUSION 2200, INCFQH2026-03-05
00075450844337Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
00850073677032Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677056Skin-ClensAsept Pak, Inc.FQH2026-02-17
10850073677008Shur-ClensAsept Pak, Inc.FQH2025-04-30
10860006476035Shur-ClensAsept Pak, Inc.FQH2025-04-23
10850073677015Shur-ClensAsept Pak, Inc.FQH2025-04-16
10860006476028Shur-ClensAsept Pak, Inc.FQH2025-04-16
10842351180027Irrisept Accessory KitIRRIMAX CORPORATIONFQH2024-07-22
10842351120047Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
10842351180010Irrisept Wound Solution KitIRRIMAX CORPORATIONFQH2024-07-01
06951233720125CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720316CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720330CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720361CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720378palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720507palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720545CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720569PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720958PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11