FDA.reportPublic FDA data

Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C

Primary DI
04251783104133
Brand
Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C
Company
Assamed GmbH - Medizinbedarf
Model
04366300
Device description
Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C
Published
2023-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14251783104130PackageGS14In Commercial Distribution
24251783104137PackageGS1104In Commercial Distribution
04251783104133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425178310413014251783104130
2425178310413724251783104137
04251783104133042517831041334251783104133

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.

Contacts#

Phone, Email table
PhoneEmail
+49(0)682681155thomas.flamm@assamed.de

Regulatory Flags#

DUNS number
319354346
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
04251783104454Irrigation Tubing Set 3.8 mWH.41 blau2026-04-24
04251783104195Y-Connector060164002023-04-03
14251783104192Y-Connector060164002023-04-03
04251783104164Reusable Irrigation Tubing Set 2.2 m047194002023-03-31
04251783104171Reusable Irrigation Tubing Set for elcoMED SA 200/ SA200C 2.2 m049767002023-03-31
14251783104161Reusable Irrigation Tubing Set 2.2 m047194002023-03-31
14251783104178Reusable Irrigation Tubing Set for elcoMED SA 200/ SA200C 2.2 m049767002023-03-31
14251783104130Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C043663002023-03-30
04251783104010Irrigation Tubing with Luer-Lock (disposable) 2.2m009293002023-03-29
04251783104041Irrigation Tubing with Luer-Lock (disposable) 3.8 m009294002023-03-29
04251783104072Irrigation Tubing Set 2.2 m043636002023-03-29
04251783104102Irrigation Tubing Set 3.8 m043641002023-03-29
04251783104119Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m043651002023-03-29
04251783104126Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 2.2 m043653002023-03-29
04251783104188Suction Tubing Set 2 m053545002023-03-29
14251783104017Irrigation Tubing with Luer-Lock (disposable) 2.2m009293002023-03-29
14251783104048Irrigation Tubing with Luer-Lock (disposable) 3.8 m009294002023-03-29
14251783104079Irrigation Tubing Set 2.2 m043636002023-03-29
14251783104109Irrigation Tubing Set 3.8 m043641002023-03-29
14251783104116Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m043651002023-03-29

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