FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471189249
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
P31-702
Catalog number
P31-702
Device description
ECO PULSE KIT- SHOWER SPRAY & FEM. BRUSH WITH SUCTN- STRYKER
Published
2022-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05051471189249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051471189249050514711892495051471189249

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation system nozzleA surgically-invasive device designed to be attached to the distal end of a lavage system or kit handpiece to intraoperatively function as an applicator/nozzle that produces an intentional jet, stream or spray of sterile fluid (typically saline) from its aperture to the site of operation during a surgical intervention (e.g., trauma, soft tissue application and orthopaedic) for the purpose of removing tissue, bone debridement and/or bone cement residue, and to clean the site; it may in addition perform aspiration (suction). It is available in many designs (e.g., fan spray, built-in filter, splash shield, brush); however, it is not a single-hole cannula/tubing. This is a single-use device.

Regulatory Flags#

DUNS number
458064144
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
true
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
05051471023413De Soutter MedicalS17-036S17-0362022-11-22
05051471023758De Soutter MedicalS32-128S32-1282022-11-22
05051471023888De Soutter MedicalS33-132S33-1322022-11-22
05051471027725De Soutter MedicalR25-209R25-2092022-11-29
05051471028074De Soutter MedicalS92-120S92-1202022-11-22
05051471028098De Soutter MedicalS92-121S92-1212022-11-22
05051471028111De Soutter MedicalS92-122S92-1222022-11-22
05051471028135De Soutter MedicalS92-123S92-1232022-11-22
05051471028159De Soutter MedicalS92-124S92-1242022-11-22
05051471028173De Soutter MedicalS92-125S92-1252022-11-22
05051471028197De Soutter MedicalS92-126S92-1262022-11-22
05051471028258De Soutter MedicalS92-133S92-1332022-11-22
05051471028272De Soutter MedicalS92-220S92-2202022-11-18
05051471028296De Soutter MedicalS92-221S92-2212022-11-18
05051471028319De Soutter MedicalS92-224S92-2242022-11-23
05051471028333De Soutter MedicalS92-226S92-2262022-11-23
05051471028371De Soutter MedicalS92-234S92-2342022-11-23
05051471028395De Soutter MedicalS92-236S92-2362022-11-23
05051471028418De Soutter MedicalS92-263S92-2632022-11-23
05051471028432De Soutter MedicalS92-140S92-1402022-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FQH2026-10-16
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
06951233720170CLEANESTGuangzhou 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