FDA.reportPublic FDA data

AWCduo

Primary DI
04260206311911
Brand
AWCduo
Company
Ovesco Endoscopy AG
Model
124 cm
Catalog number
200.57.05
Device description
The AWCduo is an additional working channel for flexible endoscopes • external channel for insertion of instruments or flushing and suction • it consists of: flexible cap (for endoscope diameters from 9.8 mm to 11.5 mm) AWCduo working channel with connector and valve with Luer Lock connection AWCduo mounting clasp with fastening strap for fixation at the endoscope handle endoscope sleeve adhesive tapes for fixation • for gastroscopes with insertion length of 103 - 110 cm
Published
2025-06-05
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260206311904PackageGS12In Commercial Distribution
04260206311911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260206311904042602063119044260206311904
04260206311911042602063119114260206311911

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope channel support kitA collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+19196519449customerservice@ovesco-usa.com
+49707196528160service@ovesco.com

Regulatory Flags#

DUNS number
344007369
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260206311966BougieCap PP400.402026-01-16
04260206311935AWCduo184 cm200.57.062025-06-05
04260206310983BARS SetBARS Set100.602024-11-29
04260206310648Traction Polypectomy Snare220 cm200.55.102016-09-16
04260206311010colonic FTRD Set14200.702018-05-28
04260206311027Coag Dissector165 cm200.502018-07-05
04260206311034AqaNife1.5 mm200.53.012018-10-02
04260206311041AqaNife2.0 mm200.53.022018-10-02
04260206311058AqaNife2.5 mm200.53.032018-10-02
04260206311065AqaNife3.0 mm200.53.042018-10-02
04260206311072diagnostic FTRD Set13200.762018-10-02
04260206311003LiftUpLiftUp200.56.012022-08-22
04260206311355LiftUp KitLiftUp Kit200.56.022022-08-22
04260206311263BARS Anchor silver165 cm200.122022-11-22
04260206311270BARS Anchor black165 cm200.132022-11-22
04260206310143OTSC Anchor165 cm200.102016-09-16
04260206310228OTSC Twin Grasper165 cm200.442016-09-16
04260206310235OTSC Twin Grasper220 cm200.452016-09-16
04260206310273OTSC Proctology Anchor38 cm200.612016-09-16
04260206310297OTSC Anchor 220tt220 cm200.112016-09-16

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