Natus

GUDID 26955739013570

Xi'an Friendship Medical Electronics Co.,Ltd.

Nerve-locating probe, single-use Nerve-locating probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use

• Primary Device ID: 26955739013570
• NIH Device Record Key: add536a5-0b5e-40b9-a42d-cf39c79e8cb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natus
• Version Model Number: 017512
• Company DUNS: 529249095
• Company Name: Xi'an Friendship Medical Electronics Co.,Ltd.
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16955739013573 [Primary]
GS1	26955739013570 [Package]; Contains: 16955739013573; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112426

FDA Product Code

• ETN: Stimulator, Nerve

Sterilization

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

[26955739013570]

Ethylene Oxide

[26955739013570]

Ethylene Oxide

[26955739013570]

Ethylene Oxide

[26955739013570]

Ethylene Oxide

[26955739013570]

Ethylene Oxide

[26955739013570]

Ethylene Oxide

[26955739013570]

Ethylene Oxide

[26955739013570]

Ethylene Oxide

[26955739013570]

Ethylene Oxide

[26955739013570]

Ethylene Oxide

[26955739013570]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-28