FDA.reportPublic FDA data

CLEANEST

Primary DI
06951233720330
Brand
CLEANEST
Company
Guangzhou Clean Medical Products Manufacturing Corp.
Model
W-202-P11(EC)
Catalog number
W-202-P11(EC)
Device description
Large Splash Shield[For use with Disposable Electronically Pulsed Lavage Suction Apparatus (Model No.: W-202, W-203, W-205)]
Published
2024-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
06951233720330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06951233720330069512337203306951233720330

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529707388
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06951233720842PALAGUN®CL006-02E(CM194)CL006-02E(CM194)2025-06-05
06951233721610CLEANESTCL006-06A1-02E2024-05-15
06951233721634CLEANESTCL006-06A2-01E2024-05-15
06951233721658CLEANESTCL006-06A2-02E2024-05-15
06951233721665CLEANESTCL006-06B1-01E2024-05-15
06951233721672CLEANESTCL006-06B1-02E2024-05-15
06951233721696CLEANESTCL006-06B2-01E2024-05-15
06951233721719CLEANESTCL006-06B2-02E2024-05-15
06951233721726CLEANESTCL006-06C1-01E2024-05-15
06951233721733CLEANESTCL006-06C1-02E2024-05-15
06951233721757CLEANESTCL006-06C2-01E2024-05-15
06951233721771CLEANESTCL006-06C2-02E2024-05-15
06951233721788CLEANESTCL006-06-17E2024-05-15
06951233721795CLEANESTCL006-06-18E2024-05-15
06951233721603CLEANESTCL006-06A1-01E2024-05-13
04260102136038HeraeusCL006-01-18(CM194)CL006-01-18(CM194)2024-04-11
06951233720125CLEANESTW-202-B(EC)W-202-B(EC)2024-04-11
06951233720170CLEANESTW-202-P3(EC)W-202-P3(EC)2024-04-11
06951233720316CLEANESTW-202-P4(EC)W-202-P4(EC)2024-04-11
06951233720361CLEANESTW-202-P1(EC)W-202-P1(EC)2024-04-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471221512De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2026-05-27
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B674T93LF10PerilavStiehl Tech, LLCFQH2026-05-13
07640407460811debritom+Medaxis AGFQH2026-04-17
07649996166302debritom+Medaxis AGFQH2026-04-17
07649996166043debritom+Medaxis AGFQH2026-04-08
04050147023826ErbeErbe Elektromedizin GmbHFQH2026-04-01
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
04050147022959ErbeErbe Elektromedizin GmbHFQH2025-10-01
04050147022942ErbeErbe Elektromedizin GmbHFQH2025-09-30
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
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03600040970614ElefantColoplast A/SFQH2024-04-05
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03600040970737ElefantColoplast A/SFQH2024-04-05
03600040970768ElefantColoplast A/SFQH2024-04-05
03600040970799ElefantColoplast A/SFQH2024-04-05
00034197018470Premier Solution Saline Wound WashPremier Brands of America Inc.FQH2024-03-12
00032251985164Family Wellness Saline Wound WashFamily Dollar StoresFQH2024-03-10