EDGE ENDO EEALU

GUDID 00810988031299

EdgeApex Apex Locator

HANDPIECE PARTS & REPAIRS, INC.

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• Primary Device ID: 00810988031299
• NIH Device Record Key: badfd9a1-c450-4de2-97fd-095230a0e2ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDGE ENDO
• Version Model Number: EEALU
• Catalog Number: EEALU
• Company DUNS: 079723355
• Company Name: HANDPIECE PARTS & REPAIRS, INC.
• 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: 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	00810988031299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181087

FDA Product Code

• LQY: Locator, Root Apex

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-27
• Device Publish Date: 2023-04-19

On-Brand Devices [EDGE ENDO]

• 00810988031190: EDGE APEX MEASURING WIRE
• 00810988031183: EDGE APEX CONTRA ANGLE
• 00810988031169: EDGE APEX CORDLESS ENDODONTIC HANDPIECE
• 00810988031237: EDGE APEX SILICONE COVERS
• 00810988031213: EDGE APEX LIP HOOKS
• 00810988031206: EDGE APEX FILE CLIPS
• 00810988031220: EDGE APEX TOUCH PROBE
• 00810988031299: EdgeApex Apex Locator
• 00810988031329: EdgeApex File Clips (5 pack)
• 00810988031305: EdgeApex Lip Hooks (5 Pack)
• 00810988031633: EdgeFlow E25G-NR Injection needle
• 00810988031626: EdgeFlow E23G-NR Injection needle
• 00810988031619: EdgeFlow E20G-NR Injection needle
• 00810988031602: EdgeFlow E25G-L Injection needle
• 00810988031596: EdgeFlow E25G-M Injection needle
• 00810988031589: EdgeFlow E23G-L Injection needle
• 00810988031572: EdgeFlow E23G-M Injection needle
• 00810988031565: EdgeFlow E20G-L Injection needle
• 00810988031558: EdgeFlow E20G-M Injection needle
• 00810988031541: EdgeFlow E20G-S Injection needle
• 00810988031497: EdgeFlow Obturation Unit
• 00810988031480: EdgePack 6012 Tip
• 00810988031473: EdgePack 5508L Tip
• 00810988031466: EdgePack 5510 Tip
• 00810988031459: EdgePack 5508 Tip
• 00810988031442: EdgePack 5506 Tip
• 00810988031435: EdgePack 5004 Tip
• 00810988031428: EdgePack 4504 Tip
• 00810988031411: EdgePack 4004 Tip
• 00810988031404: EdgePack 3504 Tip
• 00810988031374: EdgePack Downpack Unit
• 00810988031350: EdgeApex Tester
• 00810988031336: EdgeApex Measuring Wire
• 00810988031312: EdgeApex Measuring File