FDA.reportPublic FDA data

De Soutter Medical

Primary DI
05051471215283
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
21530
Catalog number
21530
Device description
IRRIGATION SLEEVE - FOR USE WITH AV-220 (9770)
Published
2025-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051471215283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051471215283050514712152835051471215283

GMDN Terms#

Term, Definition table
TermDefinition
Medical/surgical interventional tube/cable securement clip, reusableA device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters, irrigation tubing) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
458064144
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051471223875De Soutter MedicalS89-9535S89-95352026-06-03
05051471223639De Soutter MedicalS86-1585S86-15852026-06-01
05051471221512De Soutter MedicalT20-122T20-1222026-05-27
05051471221697De Soutter Medical21640216402026-05-27
05051471221703De Soutter Medical21650216502026-05-27
05051471221710De Soutter Medical21660216602026-05-27
05051471220195De Soutter Medical21630216302026-03-24
05051471011519De Soutter Medical517051702022-11-28
05051471220812De Soutter MedicalS83-8069S83-80692026-03-02
05051471220836De Soutter MedicalS83-8169S83-81692026-03-02
05051471220263De Soutter MedicalS89-1482S89-14822026-01-29
05051471219625De Soutter MedicalS83-9499S83-94992026-01-05
05051471198777De Soutter MedicalT20-101T20-1012023-06-16
05051471197220De Soutter Medical20460204602023-06-16
05051471219038De Soutter MedicalS83-9399S83-93992025-12-04
05051471219175De Soutter MedicalS56-9655S56-96552025-12-04
05051471219199De Soutter MedicalS89-9655S89-96552025-12-04
05051471044845De Soutter Medical881088102022-11-28
05051471078581De Soutter Medical128277412827742022-11-25
05051471023321De Soutter MedicalS12-272S12-2722022-11-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05051471223639De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-06-01
05051471221697De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221703De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221710De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
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