HEINE LI-ION BATTERY

GUDID B099X007996760

HEINE LI-ION BATTERY FOR MPACK AND MPACK LL

SONTEC INSTRUMENTS, INC.

Indirect binocular ophthalmoscope, battery-powered

• Primary Device ID: B099X007996760
• NIH Device Record Key: 45a4a6ae-5f39-4d38-a7a1-63da469ea5da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEINE LI-ION BATTERY
• Version Model Number: X-007.99.676
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896009592 [Primary]
HIBCC	B099X007996760 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142486

FDA Product Code

• HLJ: Ophthalmoscope, Battery-Powered

Sterilization

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

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

[B099X007996760]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-08-24

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