ComforTen® 60-hole covered tray 8000001372

GUDID 00365044000080

60 hole test tray.

Jubilant Hollisterstier LLC

Allergy testing lancet

• Primary Device ID: 00365044000080
• NIH Device Record Key: df86a490-f21a-47af-811b-5aab1c48ab44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComforTen® 60-hole covered tray
• Version Model Number: 8000001372
• Catalog Number: 8000001372
• Company DUNS: 119241112
• Company Name: Jubilant Hollisterstier LLC
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com
• Phone: 800.495.7437
• Email: HollisterStier@jubl.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365044000080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953939

FDA Product Code

• LDG: Kit, Earmold, Impression

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: 2026-03-10
• Device Publish Date: 2026-03-02

On-Brand Devices [ComforTen® 60-hole covered tray]

• 00365044000066: 60 hole test tray
• 00365044000080: 60 hole test tray.