FDA.reportPublic FDA data

debritom+

Primary DI
07649996166159
Brand
debritom+
Company
Medaxis AG
Model
2000.2000
Device description
"debritom+ AeroGuard ""Jellyfish"""
Published
2021-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
07649996166166PackageGS110Not in Commercial Distribution
B724200020000PreviousHIBCC0
07649996166159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649996166166076499961661667649996166166
07649996166159076499961661597649996166159

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.

Contacts#

Phone, Email table
PhoneEmail
+41628238800info@medaxis.ch

Regulatory Flags#

DUNS number
480870674
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07649996166050debritom+2000.02012021-09-09
07649996166074debritom+2000.02002021-09-09
07649996166111debritom+2000.00042021-09-09
07640407460811debritom+1000.05012026-04-17
07649996166302debritom+1000.00062026-04-17
07649996166043debritom+1000.05002026-04-08
07649996166036debritom+1000.00052021-09-10
07649996166098debritom+2000.00032021-09-09
07649996166135debritom+2000.00052021-09-09
07649996166067debritom+2000.02012021-09-09
07649996166081debritom+2000.02002021-09-09
07649996166104debritom+2000.00032021-09-09
07649996166128debritom+2000.00042021-09-09
07649996166142debritom+2000.00052021-09-09
07649996166166debritom+2000.20002021-09-09
B724200000030debritom+2000.00032019-04-02
B724200000040debritom+2000.00042019-02-25
B724200000050debritom+2000.00052019-04-02
B724200002010debritom+2000.02012019-04-02
B724200020000debritom+2000.20002019-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
03600040955086ElefantColoplast A/SFQH2024-04-05
03600040955116ElefantColoplast A/SFQH2024-04-05
03600040970614ElefantColoplast A/SFQH2024-04-05
03600040970645ElefantColoplast A/SFQH2024-04-05
03600040970676ElefantColoplast A/SFQH2024-04-05
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