Plasdent PS300

GUDID D832PS3002

A/W Syringe Cover, 2" X 8"

PLASDENT CORPORATION

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• Primary Device ID: D832PS3002
• NIH Device Record Key: aeddcac7-adee-4e82-a170-d4e9e3ff2302
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasdent
• Version Model Number: PS300
• Catalog Number: PS300
• Company DUNS: 190377184
• Company Name: PLASDENT CORPORATION
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D832PS3000 [Unit of Use]
HIBCC	D832PS3001 [Primary]
HIBCC	D832PS3002 [Package]; Contains: D832PS3001; Package: Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201604

FDA Product Code

• PEM: Dental Barriers And Sleeves

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: 2022-07-08
• Device Publish Date: 2022-06-30

On-Brand Devices [Plasdent]

• D832SC90607X0: Silicone Mouth Props, Small (Pedo), Orange
• D832SC90603N0: Silicone Mouth Props, Small (Pedo), Neon Yellow
• D832SC90507X0: Silicone Mouth Props, Medium (Child), Orange
• D832SC90504T0: Silicone Mouth Props, Medium (Child), Turquoise
• D832SC90407X0: Silicone Mouth Props, Large (Adult), Orange
• D832SC904010X0: Silicone Mouth Props, Large (Adult), Dark Purple
• D832SC9030110: Silicone Mouth Props, Extra Large Adult, Black
• D832SC9020110: Silicone Mouth Props, Edentulous, Black
• D832RB906090: Rubber Mouth Props, Small (Pedo), Dark Gray
• D832RB905090: Rubber Mouth Props, Medium (Child), Dark Gray
• D832RB904090: Rubber Mouth Props, Large (Adult), Dark Gray
• D832EX90600: Disposable Mouth Props, Small (Pedo), White
• D832EX90500: Disposable Mouth Props, Medium (Child), White
• D832EX90400: Disposable Mouth Props, Large (Adult), White
• D832CRH20: Cotton Roll Holders, Disposable, Blue
• D832SB0080: Jumbo Multi Steri Box, 2 Large & 4 Small Sections
• D832SB0070: Square Multi Steri Box, 2 Small Sections
• D832SB0050: Rectangular Steri Box, Capacity: 20
• D832SB0040: Small Round Steri Box, Capacity: 6
• D832SB0030: Large Round Steri Box, Capacity: 16
• D832SB0020: Rectangular Multi Steri Box, 5 Large Sections
• D832SB0010: Square Multi Steri Box, 4 Small Sections
• D832MA250: Micro Aspirators - 25 Gauge, Blue
• D832MA200: Micro Aspirators - 20 Gauge, Yellow
• D832MA180: Micro Aspirators - 18 Gauge, Pink
• D832MA010: Micro Aspirators - Untipped, Clear
• D832LLUT0: 12cc Utility Plastic Syringe, Disposable
• D832LL120: 12cc Luer Lock Syringe, Plastic, Disposable
• D832LL060: 6cc Luer Lock Syringe, Plastic, Disposable
• D832LL030: 3cc Luer Lock Syringe, Plastic, Disposable
• D832LL01B110: Uncalibrated 1cc Syringe, Black, Luer-Lock
• D832LL010: 1cc Luer Lock Syringe, Calibrated, Disposable
• D832JB0040: Jumbo Box - Multi, Multi-Function
• D832JB0030: Jumbo Box - Burs & Endo, 70 Bur, 70 Endo, 4 Vials
• D832JB0020: Jumbo Box - Endo, 144 Endo Instruments
• D832JB0010: Jumbo Box - Burs, 160 FG Burs
• D832EFIR20: Round Endo Foam Inserts, Blue
• D832EFI39X0: Rectangular Endo Foam Insert, Dark Gray
• D832EFI29X0: Square Endo Foam Inserts, Dark Gray
• D832EFI10: Triangle Endo Foam Inserts, White
• D832ED006MIX0: Square Endo Box, 18 Endo, 18 Bur, 2 Vials
• D832ED006GP0: Square Endo Box, 6 Gutta Percha Vials
• D832ED006FR0: Square Endo Box, 36 Endo Instruments
• D832ED005MIX0: Rectangular Endo Box, 30 Endo, 30 bur, 4 Vials
• D832ED005GP0: Rectangular Endo Box, 18 Gutta Percha Vials
• D832ED005FR0: Rectangular Endo Box, 72 Endo Instruments
• D832ED004MIX0: Small Round Endo Box, 9 Endo, 9 Bur, 2 Vials
• D832ED004GP0: Small Round Endo Box, 4 Gutta Percha Vials
• D832ED004FR0: Small Round Endo Box, 26 Endo Instruments
• D832ED003MIX0: Large Round Endo Box, 15 Endo, 15 Bur, 4 Vials