colonic FTRD Set

Primary DI
04260206311010
Brand
colonic FTRD Set
Company
Ovesco Endoscopy AG
Model
14
Catalog number
200.70
Device description
The colonic FTRD Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following three instruments: colonic FTRD (application cap with preloaded clip and integrated HF snare endoscope sleeve, hand wheel and thread retriever for colonoscopes) • FTRD Marking Probe (HF coagulation probe marking of the target lesion in preparation of FTRD use for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps proper grip on the target tissue precise retrieval of the sample into the application cap of the FTRD)
Published
2018-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDISnare, Flexible
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260206310556PreviousGS10
04260206311010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260206310556042602063105564260206310556
04260206311010042602063110104260206311010

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. 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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
344007369
Device count
1
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
04260206311911AWCduo124 cm200.57.052025-06-05
04260206311935AWCduo184 cm200.57.062025-06-05
04260206310983BARS SetBARS Set100.602024-11-29
04260206310648Traction Polypectomy Snare220 cm200.55.102016-09-16
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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