ROUND LOOP B1D

GUDID 00841494105389

ROUND LOOP-1/4" DIAMETER- 25PC STERILE

Ellman International

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00841494105389
• NIH Device Record Key: 059d3dbd-8789-4778-9687-37ade1f74c64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROUND LOOP
• Version Model Number: B1D
• Catalog Number: B1D
• Company DUNS: 079095245
• Company Name: Ellman International
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494105389 [Primary]
GS1	10841494105386 [Unit of Use]

FDA Product Code

• JOS: Electrode, electrosurgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-21

On-Brand Devices [ROUND LOOP]

• 00841494105389: ROUND LOOP-1/4" DIAMETER- 25PC STERILE
• 00841494105372: ROUND LOOP - 3/8" DIAMETER STERILE