Inion CPS Instrument ACC-9805

GUDID 06438408002113

Sterilization tray for instruments

Inion Oy

Instrument tray

• Primary Device ID: 06438408002113
• NIH Device Record Key: 1ef0d136-9225-4c6f-b0f1-984c6fd372be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion CPS Instrument
• Version Model Number: 1
• Catalog Number: ACC-9805
• Company DUNS: 367994657
• Company Name: Inion Oy
• 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	06438408002113 [Secondary]
HIBCC	M224ACC98059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010352

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

[06438408002113]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-21
• Device Publish Date: 2018-05-15

On-Brand Devices [Inion CPS Instrument]

• 06438408000362: Sterilization tray for instruments
• 06438408002113: Sterilization tray for instruments