Flex-X

GUDID 04048551338988

Video Neuro-Endoscope, flexible

Karl Storz GmbH & Co. KG

Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope Flexible fibreoptic intracranial/spinal endoscope

• Primary Device ID: 04048551338988
• NIH Device Record Key: aefd58a8-395a-497e-96ea-d46674297dc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex-X
• Version Model Number: 11161V
• Company DUNS: 315731430
• Company Name: Karl Storz GmbH & Co. KG
• 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	04048551338988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171402

FDA Product Code

• EOB: Nasopharyngoscope (flexible or rigid)

Sterilization

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

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

[04048551338988]

Peracetic Acid;Hydrogen Peroxide;High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-03
• Device Publish Date: 2019-02-23

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