Aptimax 13831

GUDID 20705037016065

Instrument Tray 600 mm x 200 mm x 50 mm (24 in x 8 in x 2 in)

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

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• Primary Device ID: 20705037016065
• NIH Device Record Key: 9f52aaa2-8ab9-4859-8d10-fe92070deb30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aptimax
• Version Model Number: 13831
• Catalog Number: 13831
• Company DUNS: 947451626
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES 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: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: complaints@aspus.jnj.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037016068 [Primary]
GS1	20705037016065 [Package]; Contains: 10705037016068; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013003

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: 6
• Public Version Date: 2020-10-21
• Device Publish Date: 2016-09-24

On-Brand Devices [Aptimax]

• 20705037064486: Instrument Tray 278 mm x 270 mm x 100 mm (11 in x 10-5/8 in x 4 in)
• 10705037048649: Instrument Tray Kit
• 10705037047611: Aptimax Tray Kit
• 10705037016136: Instrument Tray 596 mm x 321 mm x 100 mm (23-15/32 in x 12-21/32 in x 4 in)
• 20705037016126: Instrument Tray 576 mm x 270 mm x 100 mm (22-11/16 in x 10-5/8 in x 4 in)
• 10705037016112: Instrument Tray 278 mm x 270 mm x 100 mm (11 in x 10-5/8 in x 4 in)
• 20705037016102: Instrument Tray 380 mm x 250 mm x 30 mm (15 in x 10 in x 1.2 in)
• 20705037016096: Instrument Tray 380 mm x 150 mm x 30 mm (15 in x 6 in x 1.2 in)
• 20705037016089: Instrument Tray 250 mm x 150 mm x 30 mm (10 in x 6 in x 1.2 in)
• 20705037016072: Instrument Tray 180 mm x 75 mm x 30 mm (7 in x 3 in x 1.2 in)
• 20705037016065: Instrument Tray 600 mm x 200 mm x 50 mm (24 in x 8 in x 2 in)
• 20705037016058: Instrument Tray 450 mm x 200 mm x 50 mm (18 in x 8 in x 2 in)
• 20705037016041: Instrument Tray 300 mm x 200 mm x 50 mm (12 in x 8 in x 2 in)
• 20705037016034: Instrument Tray 600 mm x 100 mm x 50 mm (24 in x 4 in x 2 in)
• 20705037016027: Instrument Tray 450 mm x 100 mm x 50 mm (18 in x 4 in x 2 in)
• 20705037016010: Instrument Tray 300 mm x 100 mm x 50 mm (12 in x 4 in x 2 in)