Plasdent Clear Protection Sterilization Pouch POH712-13

GUDID D832POH712135

Autoclave Pouches 7 1/2" x 13", Dual Indicator (200pcs/box)

PLASDENT CORPORATION

Sterilization packaging, single-use

• Primary Device ID: D832POH712135
• NIH Device Record Key: 0868d1d2-56f9-4cb4-bd5e-1a7ec760523b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasdent Clear Protection Sterilization Pouch
• Version Model Number: POH
• Catalog Number: POH712-13
• 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	D832POH71213 [Primary]
HIBCC	D832POH712131 [Package]; Contains: D832POH71213; Package: box [200 Units]; In Commercial Distribution
HIBCC	D832POH712132 [Package]; Contains: D832POH712131; Package: Case [10 Units]; In Commercial Distribution
HIBCC	D832POH712135 [Package]; Contains: D832POH71213; Package: case [2000 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

On-Brand Devices [Plasdent Clear Protection Sterilization Pouch]

• D832POH712135: Autoclave Pouches 7 1/2" x 13", Dual Indicator (200pcs/box)
• D832POH514105: Autoclave Pouches 5 1/4" x 10", Dual Indicator (200pcs/box)
• D832POH414125: Autoclave Pouches 4 1/4" x 12", Dual Indicator (200pcs/box)
• D832POH31295: Autoclave Pouches 3 1/2" x 9", Dual Indicator (200pcs/box)
• D832POH3125145: Autoclave Pouches 3 1/2" x 5 1/4", Dual Indicator (200pcs/box)
• D832POH295: Autoclave Pouches 2" x 9", Dual Indicator (200pcs/box)
• D832POH23495: Autoclave Pouches 2 3/4" x 9", Dual Indicator (200pcs/box)
• D832POH21445: Autoclave Pouches 2 1/4" x 4", Dual Indicator (200pcs/box)
• D832POH12155: Autoclave Pouches 12" x 15", Dual Indicator (100pcs/box)
• D832POH10155: Autoclave Pouches 10" x 15", Dual Indicator (100pcs/box)