Sphincterotome short-wire compatible

Basic Information

• Brand Name: Sphincterotome short-wire compatible
• Primary DI: 06932503575331
• Version / Model: RDSP-0530-122
• Company Name: Micro-Tech (Nanjing) Co., Ltd.
• Labeler DUNS: 530269083
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-03
• Public Version: 5
• Public Version Date: 2025-12-04
• Public Version Status: Update
• Public Device Record Key: d0f21b68-32aa-491d-946e-ae449118e00a

Device Description

Sphincterotome / short-wire compatible, lumen 3, TIP length 5mm, cutting wire 30mm, Outside diameter 2.5mm, Cone, no half Insulation, preload 2.6m guidewire, Weave Cutting wire

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58039	Endoscopic electrosurgical handpiece/electrode, monopolar, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16932503575338	GS1	BOX	1	In Commercial Distribution
Primary	06932503575331	GS1
Package	26932503575335	GS1	CASE	25	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K210934	000

Device Sizes

Type	Value	Unit	Text
Atherectomy Device Tip Length	5	Millimeter
Atherectomy Cutter Length	30	Millimeter