LIGHT SOURCE

GUDID 04961333232802

LH-150PC LIGHT SOURCE (REFURBISHED)

PENTAX OF AMERICA, INC.

Endoscopic light source, line-powered

• Primary Device ID: 04961333232802
• NIH Device Record Key: e750085a-bc51-464b-9db6-59be50fe93db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIGHT SOURCE
• Version Model Number: LH-150PC
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, 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: true
• 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	04961333232802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K771739

FDA Product Code

• FCW: Light Source, Fiberoptic, Routine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2017-04-06

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• 04961333248445 - C2 CryoBalloon Nitroclip: 2020-08-17 NitroClip
• 00854924006408 - C2 CryoBalloon EndoGrip: 2020-08-06 EndoGrip
• 04961333248001 - ENDOPRO REVIEW WORKSTATION: 2020-04-03 ENDOPRO REVIEW WORKSTATION
• 04961333248018 - ENDOPRO NETWORK CAPTURE WORKSTATION: 2020-04-03 ENDOPRO CAPTURE WORKSTATION, NETWORK