Opa Mixer/tip TIPYLB

GUDID D815TIPYLB11111

Oral tip light body 6 pcs

OPA DENTAL LLC

Dental material injection cannula, single-use

• Primary Device ID: D815TIPYLB11111
• NIH Device Record Key: b717e12a-e536-4585-be56-0904528e5aa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opa Mixer/tip
• Version Model Number: TIPYLB
• Catalog Number: TIPYLB
• Company DUNS: 053308044
• Company Name: OPA DENTAL LLC
• 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: 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
HIBCC	D815TIPYLB01 [Unit of Use]
HIBCC	D815TIPYLB11111 [Primary]

FDA Product Code

• EID: Syringe, Restorative And Impression Material

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: 2019-08-21
• Device Publish Date: 2018-11-26

On-Brand Devices [Opa Mixer/tip]

• D815TIPYLB11111: Oral tip light body 6 pcs
• D815TIPYLB1: Oral tip light body 6 pcs
• D815MIXERYLB1: Mixer light body 6 pcs
• D815MIXERBHB1: Mixer heavy body 6 pcs
• D815MIXERHBLG01: Mixer auto 380ml heavy body 10 pcs