ProView Plus PM3590-1

GUDID H816MPM35902

Self Sealing Sterilization Pouch, 3.5" x 9"

MicroCare, LLC

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• Primary Device ID: H816MPM35902
• NIH Device Record Key: 3820ac12-1473-413e-880a-d83a7f728c2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProView Plus
• Version Model Number: PM3590
• Catalog Number: PM3590-1
• Company DUNS: 118518186
• Company Name: MicroCare, LLC
• Device Count: 200
• 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: true
• 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	H816MPM35900 [Unit of Use]
HIBCC	H816MPM35901 [Primary]
HIBCC	H816MPM35902 [Package]; Contains: H816MPM35901; Package: Case Box [6 Units]; In Commercial Distribution
HIBCC	H816PM35901 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953829

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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: 2022-11-03
• Device Publish Date: 2022-10-26

On-Brand Devices [ProView Plus]

• H816MPM75132: Self Sealing Sterilization Pouch, 7.5" x 13"
• H816MPM54102: Self Sealing Sterilization Pouch, 5.25" x 10"
• H816MPM35902: Self Sealing Sterilization Pouch, 3.5" x 9"
• H816MPM35542: Self Sealing Sterilization Pouch, 3.5" x 5.25"
• H816MPM27902: Self Sealing Sterilization Pouch, 2 3/4" x 9"
• H816MPM24402: Self Sealing Sterilization Pouch, 2 1/4" x 4"
• H816MPM13180: Self Sealing Sterilization Pouch, 13" x 18"
• H816MPM10160: Self Sealing Sterilization Pouch, 10"x 16"https://gudid.fda.gov/gudid/app/admin/udi/recordDetail