FDA.reportPublic FDA data

Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m

Primary DI
14251783104116
Brand
Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m
Company
Assamed GmbH - Medizinbedarf
Model
04365100
Device description
Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m
Published
2023-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
14251783104116PackageGS16In Commercial Distribution
24251783104113PackageGS1180In Commercial Distribution
04251783104119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425178310411614251783104116
2425178310411324251783104113
04251783104119042517831041194251783104119

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.8Meter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
319354346
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04251783104133Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C043663002023-03-30
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

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