Device
Sphincterotome / short-wire compatible, lumen 3, TIP length 2mm, cutting wire 20mm, Outside diameter 2.5mm, Cone, half Insulation, no preload guidewire, Single Cutting wire, Tip di...
Manufacturer
Micro-Tech (Nanjing) Co., Ltd.
Micro-Tech (Nanjing) Co., Ltd.
Model: RDSP-0220-211
DI: 06932503575386
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
Sphincterotome / short-wire compatible, lumen 3, TIP length 2mm, cutting wire 20mm, Outside diameter 2.5mm, Cone, half Insulation, no preload guidewire, Single Cutting wire, Tip diameter:4.9Fr
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
322d069c-2bc9-43c6-8cb3-075bceda64b1
Distribution Status:
In Commercial Distribution
DUNS Number:
530269083
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
BOX
Item #1 - Device ID:
16932503575383
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06932503575386
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06932503575386
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
CASE
Item #3 - Device ID:
26932503575380
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
25
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
16932503575383
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 58039
Name: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Definition:
An 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.
FDA Product Codes
KNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Premarket Submissions
Submission Number:
K210934
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
2
Item #1 - Size Type:
Atherectomy Device Tip Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
20
Item #2 - Size Type:
Atherectomy Cutter Length