PLEATMAN SAC, Reusable Introducer

GUDID 00821925000131

"INTRODUCER, PLEATMAN SAC"

Gyrus Acmi, Inc.

Tissue extraction bag

• Primary Device ID: 00821925000131
• NIH Device Record Key: fc2b0905-1fcb-4911-8619-f36031415390
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLEATMAN SAC, Reusable Introducer
• Version Model Number: 005326-901
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925000131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923945

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

[00821925000131]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-07

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