Plasdent Clear Protection Sterilization Pouch POH234-9

GUDID D832POH23495

Autoclave Pouches 2 3/4" x 9", Dual Indicator (200pcs/box)

PLASDENT CORPORATION

Sterilization packaging, single-use

• Primary Device ID: D832POH23495
• NIH Device Record Key: 2385990c-0b72-4b66-8ed4-58fa404e273d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasdent Clear Protection Sterilization Pouch
• Version Model Number: POH
• Catalog Number: POH234-9
• Company DUNS: 190377184
• Company Name: PLASDENT CORPORATION
• 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: 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	D832POH2349 [Primary]
HIBCC	D832POH23491 [Package]; Contains: D832POH2349; Package: box [200 Units]; In Commercial Distribution
HIBCC	D832POH23492 [Package]; Contains: D832POH23491; Package: Case [20 Units]; In Commercial Distribution
HIBCC	D832POH23495 [Package]; Contains: D832POH2349; Package: case [4000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172280

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-09-24

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