ACE TIP ELECTRODE TRBBB

GUDID 00841494104436

RODIN 5/32" RND LOOP 1.5 L,1/16" .007 WR

Ellman International

Open-surgery electrosurgical electrode, monopolar, reusable

• Primary Device ID: 00841494104436
• NIH Device Record Key: 1b19177b-f2af-4d53-a99a-e7412b8bde43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE TIP ELECTRODE
• Version Model Number: TRBBB
• Catalog Number: TRBBB
• 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	00841494104436 [Primary]
GS1	00841494106393 [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]

• 00841494104498: RODIN VARI ACE-TIP 1.5 , 1/16" BENDABLE
• 00841494104450: RODIN MICROINCISION ACE-TIP 1.5"L, 1/16"
• 00841494104443: RODIN ACETIP SET 1.5", 1/16" SHAFT, BEND
• 00841494104436: RODIN 5/32" RND LOOP 1.5 L,1/16" .007 WR