FDA.reportPublic FDA data

NA

Primary DI
05060247265100
Brand
NA
Company
MEDISAFE UK LIMITED
Model
MP21833
Catalog number
IW1065
Device description
The Si Multi Basket with 10 Tubing is used with the IW PCF and SI PCF S Sonic Irrigators.
Published
2021-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MECDisinfector, medical devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MECDisinfector, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060247265107PackageGS110In Commercial Distribution
05060247265100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506024726510715060247265107
05060247265100050602472651005060247265100

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer/disinfector rackA non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999info@medisafeinternational.com

Regulatory Flags#

DUNS number
505942961
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995152819NAIW1008IW10082017-02-21
05060247261973NASonic Irrigator PCFMED111322016-09-16
05060247262000NAPCF PROMED11180USA2016-09-16
05060247262093NANiagara MED1450MED14502016-09-20
05060247262116NANiagara MED1451MED14512016-09-20
15060247261871Distal Tip SoakerDistal DuckM204132021-03-31
15060247263318Duck BagDuck BagM203502021-03-31
15060247263325Duck BagDuck BagM203582021-03-31
15060247263332Duck BagDuck BagM203592021-03-31
05060247263199Distal DuckDistal DuckM204002021-03-31
00724995152710InnoWavePCFIWPCF2017-02-21
00724995152741InnoWaveProIWPRO602017-02-21
05060247265179NiagaraMP21852IW10492021-03-18
00724995152727InnoWaveIWULTRAPLIWULTRAPL2021-03-31
00724995152734InnoWaveIWULTRAIWULTRA2021-03-31
00724995152758InnoWaveEcoIWECO22021-03-31
00724995152765InnoWaveEcoIWECO52021-03-31
00724995168681InnoWaveUnityIW523036NPR2021-03-31
00724995168698InnoWaveUnityIW523046NPR2021-03-31
00724995193737InnoWaveUnityIW523546NPR2021-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051520024108SteelcoSTEELCO SPAMEC2026-05-26
10841736125257Sterling WashersSKYTRON LLCMEC2026-04-26
08051520022876SteelcoSTEELCO SPAMEC2026-04-17
08051520022852SteelcoSTEELCO SPAMEC2026-03-27
08051520022869SteelcoSTEELCO SPAMEC2026-02-04
04002516952589SteelcoMiele & Cie. KGMEC2026-01-04
04002516952749SteelcoMiele & Cie. KGMEC2026-01-04
04002516952848SteelcoMiele & Cie. KGMEC2026-01-04
04002516952947SteelcoMiele & Cie. KGMEC2026-01-04
10841736125141CleanStartSKYTRON LLCMEC2025-12-19
10841736125158CleanStartSKYTRON LLCMEC2025-12-19
10841736125165CleanStartSKYTRON LLCMEC2025-12-19
10841736125172CleanStartSKYTRON LLCMEC2025-12-19
10841736125189CleanStartSKYTRON LLCMEC2025-12-19
10841736125196CleanStartSKYTRON LLCMEC2025-12-19
10841736125202CleanStartSKYTRON LLCMEC2025-12-19
10841736125219CleanStartSKYTRON LLCMEC2025-12-19
10724995220614VERIFYALBERT BROWNE LIMITEDMEC2025-12-17
00724995220617VERIFYALBERT BROWNE LIMITEDMEC2025-12-17
10841736124427Sterling SKYTRON LLCMEC2025-12-09
10841736124434Sterling SKYTRON LLCMEC2025-12-09
08051520021176SteelcoSTEELCO SPAMEC2025-10-28
08051520021770SteelcoSTEELCO SPAMEC2025-09-24
08051520021763SteelcoSTEELCO SPAMEC2025-09-16
00848530020118CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-28
00848530096564CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530020101CPAP Cleaning SUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530080525 Germicidal Deodorizing CleanserSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530084813CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530087067CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27