SOLEIL

GUDID D838BC125SS8

Disposable Curing Light Sleeves

Premium Plus International Limited

Instrument/equipment drape, single-use, non-sterile

• Primary Device ID: D838BC125SS8
• NIH Device Record Key: e0c54ad8-3a61-4f22-a3e3-b00cef2432a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLEIL
• Version Model Number: 125SS
• Company DUNS: 668367758
• Company Name: Premium Plus International Limited
• Device Count: 500
• 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: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D838BC125SS0 [Unit of Use]
HIBCC	D838BC125SS2 [Primary]
HIBCC	D838BC125SS6 [Package]; Contains: D838BC125SS2; Package: carton [10 Units]; In Commercial Distribution
HIBCC	D838BC125SS8 [Package]; Contains: D838BC125SS6; Package: case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163447

FDA Product Code

• PEM: Dental Barriers And Sleeves

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: 2017-07-12

On-Brand Devices [SOLEIL]

• D838BC125SS8: Disposable Curing Light Sleeves
• D838BC123SS8: Disposable Curing Light Sleeves