ACE-TIP ELECTRODE TNAEE285

GUDID 00841494103385

HLTZ TONSILLOTOMY 12MM LOOP, .010 WIRE

Ellman International

Open-surgery electrosurgical electrode, monopolar, reusable

• Primary Device ID: 00841494103385
• NIH Device Record Key: c4089aba-cef2-483a-8054-9054c02cd112
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE-TIP ELECTRODE
• Version Model Number: TNAEE285
• Catalog Number: TNAEE285
• Company DUNS: 079095245
• Company Name: Ellman International
• Device Count: 2
• DM Exempt: true
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494103385 [Primary]
GS1	00841494105945 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071343

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [ACE-TIP ELECTRODE]

• 00841494104986: VARI-TIP ACE-TIP 1/16", BENDABLE
• 00841494103408: HLTZ TONSILLOTOMY ACE-TIP SET OF 3, 1/16
• 00841494103392: HLTZ TONSILLOTOMY 15MM LOOP, .010 WIRE
• 00841494103385: HLTZ TONSILLOTOMY 12MM LOOP, .010 WIRE
• 00841494103033: EMPIRE MICROINCISION ACE-TIP 1/16" SHAFT
• 00841494101763: 5MM TAPERED BALL ACE-TIP 1/16", BENDABLE
• 00841494101602: 3MM TAPERED BALL ACE-TIP 1/16", BENDABLE
• 00841494101503: 3/8" RND LOOP ACE-TIP REGULAR WIRE,1/16"
• 00841494101497: 3/8" RND LOOP ACE-TIP FINE WIRE,1/16"
• 00841494101442: 3/8" NEEDLE, 1/32" DIA. ACE-TIP, 1/16"
• 00841494101398: 3/8" NEEDLE ACE-TIP REGULAR WIRE, 1/16"
• 00841494101237: 2MM COAGULATING BALL ACE-TIP 1/16", BEND
• 00841494101145: 1CM NEEDLE, 3"CURVED SLEEVE ACE-TIP,1/16
• 00841494100902: 1/4" RND LOOP ACE-TIP REGULAR WIRE, 1/16
• 00841494100896: 1/4" RND LOOP ACE-TIP FINE WIRE, 1/16"
• 00841494100803: 1/4" TRIANGLE ACE-TIP FINE WIRE, 1/16"