ApolloVue S100 Image System

GUDID 04719878880008

APOLLO MEDICAL OPTICS, LTD.

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• Primary Device ID: 04719878880008
• NIH Device Record Key: 646dfd4e-01a8-4e2b-835b-b74e1990d390
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ApolloVue S100 Image System
• Version Model Number: S100-000US
• Company DUNS: 656285971
• Company Name: APOLLO MEDICAL OPTICS, LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719878880008 [Primary]

FDA Product Code

• NQQ: System, Imaging, Optical Coherence Tomography (Oct)

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: 2020-10-22
• Device Publish Date: 2020-10-14