Premium Plus

GUDID D838100C8

Syringe Sleeves

Premium Plus International Limited

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

• Primary Device ID: D838100C8
• NIH Device Record Key: 59be9a3b-be50-41a4-b813-96755025bd14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium Plus
• Version Model Number: 100C
• 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	D838100C0 [Unit of Use]
HIBCC	D838100C2 [Primary]
HIBCC	D838100C6 [Package]; Contains: D838100C2; Package: Box [10 Units]; In Commercial Distribution
HIBCC	D838100C8 [Package]; Contains: D838100C6; 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: 2017-06-30

On-Brand Devices [Premium Plus]

• D838C022: Dental curing light
• D8388008C8: Disposable Barrier Film
• D8388008B8: Disposable Barrier Film
• D83860158: Self Sealing Sterilization Pouches
• D83860118: Self Sealing Sterilization Pouches
• D83860098: Self Sealing Sterilization Pouches
• D83860078: Self Sealing Sterilization Pouches
• D83860052: Self Sealing Sterilization Pouches
• D83860038: Self Sealing Sterilization Pouches
• D83860018: Self Sealing Sterilization Pouches
• D83819928: Disposable Barrier Sleeves
• D83819918: Disposable Barrier Sleeves
• D83819908: Disposable Barrier Sleeves
• D8381982B8: Disposable Barrier Sleeves
• D83819828: Disposable Barrier Sleeves
• D83819818: Disposable Barrier Sleeves
• D83819808: Disposable Barrier Sleeves
• D8381908: Disposable Barrier Sleeves
• D83818928: Disposable Barrier Sleeves
• D83818918: Disposable Barrier Sleeves
• D83818908: Disposable Barrier Sleeves
• D83818848: Disposable Barrier Sleeves
• D83818838: Disposable Barrier Sleeves
• D8381882B8: Disposable Barrier Sleeves
• D83818828: Disposable Barrier Sleeves
• D83818818: Disposable Barrier Sleeves
• D83818808: Disposable Barrier Sleeves
• D83818328: Disposable Barrier Sleeves
• D83818318: Disposable Barrier Sleeves
• D8381588: Disposable Barrier Sleeves
• D8381458: Disposable Barrier Sleeves
• D838140XS8: Disposable Barrier Sleeves
• D838140S8: Disposable Barrier Sleeves
• D838140M8: Disposable Barrier Sleeves
• D838140L8: Disposable Barrier Sleeves
• D8381388: Disposable Barrier Sleeves
• D8381368: Disposable Barrier Sleeves
• D838135S8: Disposable Barrier Sleeves
• D838135L8: Disposable Barrier Sleeves
• D8381338: Disposable Barrier Sleeves
• D8381298: Disposable Barrier Sleeves
• D8381288: Disposable Barrier Sleeves
• D838125SS8: Disposable Intraoral Camera / Curing Light Sleeves
• D8381258: Disposable Barrier Sleeves
• D838123XL8: Disposable Barrier Sleeves
• D838123SS8: Disposable Curing Light Sleeves
• D838123S8: Disposable Curing Light Sleeves
• D838123L8: Disposable Barrier Sleeves
• D8381218: Disposable Barrier Sleeves
• D8381198: Disposable Barrier Sleeves