FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471198777
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
T20-101
Catalog number
T20-101
Device description
IRRIGATION KIT - METAL CUTTING - MCI
Published
2023-06-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
15051471198774PackageGS15Not in Commercial Distribution
05051471198777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505147119877415051471198774
05051471198777050514711987775051471198777

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Regulatory Flags#

DUNS number
458064144
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051471186002De Soutter Medical20250202502022-11-28
05051471186019De Soutter Medical20270202702022-11-28
05051471006942De Soutter Medical701070102022-11-28
05051471022232De Soutter Medical89522895222022-11-28
05051471040922De Soutter Medical865086502022-11-28
05051471044852De Soutter Medical882088202022-11-28
05051471005020De Soutter Medical617061702022-11-25
05051471006867De Soutter Medical75942759422022-11-25
05051471022386De Soutter Medical89932899322022-11-25
05051471027152De Soutter Medical755075502022-11-25
05051471121270De Soutter MedicalS56-703S56-7032023-06-16
05051471128217De Soutter MedicalS56-705S56-7052023-06-16
05051471118416De Soutter MedicalS56-702S56-7022023-06-16
05051471142084De Soutter Medical17670176702022-11-28
05051471225565De Soutter Medical21810218102026-08-03
05051471225541De Soutter Medical21800218002026-08-01
05051471225985De Soutter MedicalR52-220R52-2202026-08-01
05051471223844De Soutter Medical21710217102026-07-21
05051471223851De Soutter Medical21720217202026-07-21
05051471223868De Soutter Medical21730217302026-07-21

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
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
06951233720569PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11