Breiten Sterilization Tray 10965

GUDID 00816728020318

The Breiten Sterilization Tray is intended to allow sterilization of the enclosed medical devices.

INVUITY, INC.

Sterilization/disinfection container

• Primary Device ID: 00816728020318
• NIH Device Record Key: a8922756-1145-4c73-a16d-1df8e913d74a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breiten Sterilization Tray
• Version Model Number: Standard
• Catalog Number: 10965
• Company DUNS: 175697908
• Company Name: INVUITY, 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com
• Phone: 8667117768
• Email: customerservice@invuity.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0
• Width: 23 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816728020318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090070

FDA Product Code

• FST: Light, Surgical, Fiberoptic

Sterilization

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

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

[00816728020318]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-04-24
• Device Publish Date: 2016-09-22

On-Brand Devices [Breiten Sterilization Tray]

• 00816728020318: The Breiten Sterilization Tray is intended to allow sterilization of the enclosed medical device
• 00816728020301: The Breiten Sterilization Tray is intended to allow sterilization of the enclosed medical device