Plasdent Clear Protection Sterilization Pouch POH214-4

GUDID D832POH21445

Autoclave Pouches 2 1/4" x 4", Dual Indicator (200pcs/box)

PLASDENT CORPORATION

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• Primary Device ID: D832POH21445
• NIH Device Record Key: 310a9dd7-091d-46fe-9b93-86d79ae866b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasdent Clear Protection Sterilization Pouch
• Version Model Number: POH
• Catalog Number: POH214-4
• 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	D832POH2144 [Primary]
HIBCC	D832POH21441 [Package]; Contains: D832POH2144; Package: box [200 Units]; In Commercial Distribution
HIBCC	D832POH21442 [Package]; Contains: D832POH21441; Package: Case [20 Units]; In Commercial Distribution
HIBCC	D832POH21445 [Package]; Contains: D832POH2144; 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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• D832POH23495: Autoclave Pouches 2 3/4" x 9", Dual Indicator (200pcs/box)
• D832POH21445: Autoclave Pouches 2 1/4" x 4", Dual Indicator (200pcs/box)
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