DEVICE: Traction Polypectomy Snare (04260206310648)

Device Identifier (DI) Information

Traction Polypectomy Snare
220 cm
In Commercial Distribution
200.55.10
Ovesco Endoscopy AG
04260206310648
GS1

1
344007369 *Terms of Use
Ovesco’s Traction Polypectomy Snare is a newly designed, serrated snare • for endoscopic procedures such as polypectomy, endoscopic mucosa resection (EMR) or similar techniques • specific design - attached teeth to the distal part of the loop - reduces slipping of the snare upon closure • excellent maneuverability and repositioning properties • monopolar high-frequency instrument
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical 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 may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FDI Snare, Flexible
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140923 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: loop-diameter (fully open) 25 mm
Device Size Text, specify: working channel diameter 2.8 mm
Device Size Text, specify: working length 220 cm
CLOSE

Device Record Status

fa4e60f5-20b9-46e0-ba17-7abe266c8016
February 21, 2019
5
September 16, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
4260206310549 10 04260206310648 In Commercial Distribution Folding box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+49707196528160
service@ovesco.com
+19196519449
customerservice@ovesco-usa.com
CLOSE