X-FINE bipolar forceps, 80-151-17

GUDID 04250676735348

X-FINE bipolar forceps, NON-STICK , bayonet, straight tip, tip length 4 mm, 0.4 mm wide, guide pin, 17 cm

Spiggle & Theis Medizintechnik GmbH

Endoscopic electrosurgical electrode, bipolar, reusable

• Primary Device ID: 04250676735348
• NIH Device Record Key: 16f68293-6919-4ffa-b16c-e70b6c1a21bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-FINE bipolar forceps,
• Version Model Number: 80-151-17
• Catalog Number: 80-151-17
• Company DUNS: 332893028
• Company Name: Spiggle & Theis Medizintechnik GmbH
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +492206908165
• Email: c.winterschladen@spiggle-theis

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250676735348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101080

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[04250676735348]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-10
• Device Publish Date: 2019-04-02

Devices Manufactured by Spiggle & Theis Medizintechnik GmbH

• 04250381891940 - Metal bowl: 2025-06-02 B1 Ø 40 mm, height 19 mm, 20 ml
• 04250381892039 - Tablet dish: 2025-06-02 stainless steel Ø 65 mm, height 19 mm
• 04250381820421 - Expanding nasal tampon: 2025-05-29 PVA, straight 45x15x20 mm, sterile, 20 pieces/box
• 04250381820452 - Expanding nasal tampon: 2025-05-29 PVA, straight, with airway 45x15x20 mm, sterile, 20 pieces/box
• 04250676745088 - TubaVent® balloon dilatation system: 2025-03-07 TubaInsert ONE® - Type 45°, insertion device, sterile, 10 pieces
• 04250676739988 - Jackson laryngoscope: 2025-01-07 size 3, handle removable, light carrier satin finished inside, 180 mm long
• 04250676742056 - Blakesley nasal forceps, comfort: 2025-01-06 straight, golden button 4.0 mm, 12 cm
• 04250676742353 - Aufricht nasal retractor: 2025-01-06 for holding of suction tube 18.5 cm