STARlet Interface

GUDID 00858637005413

EXACT SCIENCES CORPORATION

Laboratory instrument/analyser application software IVD

• Primary Device ID: 00858637005413
• NIH Device Record Key: 2bf7e287-492c-4394-a3a1-6eca29e4a30b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARlet Interface
• Version Model Number: 2.1
• Company DUNS: 150908853
• Company Name: EXACT SCIENCES CORPORATION
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858637005413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130017

FDA Product Code

• PHP: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

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: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [STARlet Interface]

• 00858637005239: 2.0
• 00858637005413: 2.1