REAMER EPO1661

GUDID 00841494104399

REAMER, SIZE 1

Ellman International

Pin/post dental drill bit

• Primary Device ID: 00841494104399
• NIH Device Record Key: ff6b13d3-0d8b-4c6b-ba6f-d27a81719e68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAMER
• Version Model Number: EPO1661
• Catalog Number: EPO1661
• Company DUNS: 079095245
• Company Name: Ellman International
• Device Count: 6
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00841494104399 [Primary]
GS1	00841494106379 [Unit of Use]

FDA Product Code

• ELR: POST, ROOT CANAL

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: 2018-11-22
• Device Publish Date: 2016-09-21

On-Brand Devices [REAMER]

• 00841494104399: REAMER, SIZE 1
• 00841494104382: REAMER SIZE 3
• 00841494104375: REAMER SIZE 2