Sterile Sphincterotome

GUDID 16932503512395

Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 25, Outside diameter 2.5mm, Front end shape, no Rotation, half Insulation , preload guidewire, Weave Cutting wire

Micro-Tech (Nanjing) Co., Ltd.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 16932503512395
• NIH Device Record Key: 0977ba85-7ad5-4334-82e2-7eda16fa48f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Sphincterotome
• Version Model Number: DSP-30225-111222
• Company DUNS: 530269083
• Company Name: Micro-Tech (Nanjing) Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-552-4027
• Email: info@micro-tech-usa.com

Device Dimensions

• Atherectomy Device Tip Length: 2 Millimeter
• Atherectomy Cutter Length: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06932503512398 [Primary]
GS1	16932503512395 [Package]; Contains: 06932503512398; Package: BOX [1 Units]; In Commercial Distribution
GS1	26932503512392 [Package]; Package: CASE [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210934

FDA Product Code

• KNS: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-15
• Device Publish Date: 2026-01-07

On-Brand Devices [Sterile Sphincterotome]

• 16932503513200: Sterile Sphincterotome/ lumen 3/ TIP length 2/ cutting wire 25/ Outside diameter 2.5mm/ Front en
• 16932503513194: Sterile Sphincterotome/ lumen 3/ TIP length 2/ cutting wire 20/ Outside diameter 2.5mm/ Front en
• 16932503513187: Sterile Sphincterotome/ lumen 3/ TIP length 2/ cutting wire 20/ Outside diameter 2.5mm/ Front en
• 16932503512418: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 30, Outside diameter 2.5mm, Front en
• 16932503512401: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 30, Outside diameter 2.5mm, Front en
• 16932503512395: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 25, Outside diameter 2.5mm, Front en
• 16932503512388: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 25, Outside diameter 2.5mm, Front en
• 16932503512371: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 20, Outside diameter 2.5mm, Front en
• 16932503512364: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 20, Outside diameter 2.5mm, Front en
• 16932503512357: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 30, Outside diameter 2.5mm, Front en
• 16932503512340: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 30, Outside diameter 2.5mm, Front en
• 16932503512333: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 25, Outside diameter 2.5mm, Front en
• 16932503512326: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 25, Outside diameter 2.5mm, Front en
• 16932503512319: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 20, Outside diameter 2.5mm, Front en
• 16932503512302: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 20, Outside diameter 2.5mm, Front en
• 16932503512296: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 30, Outside diameter 2.5mm, Front en
• 16932503512289: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 30, Outside diameter 2.5mm, Front en
• 16932503512272: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 25, Outside diameter 2.5mm, Front en
• 16932503512265: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 25, Outside diameter 2.5mm, Front en
• 16932503512258: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 20, Outside diameter 2.5mm, Front en
• 16932503512241: Sterile Sphincterotome, lumen 3, TIP length 2, cutting wire 20, Outside diameter 2.5mm, Front en
• 16932503512234: Sterile Sphincterotome/ lumen 3/ TIP length 2/ cutting wire 30/ Outside diameter 2.5mm/ Front en
• 16932503512210: Sterile Sphincterotome/ lumen 3/ TIP length 2/ cutting wire 25/ Outside diameter 2.5mm/ Front en