Friendship Medical

GUDID 16955739030266

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: 16955739030266
• NIH Device Record Key: 07ce7a1c-01d1-4517-8519-3a6a977b9eec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Friendship Medical
• Version Model Number: PNMB0.8/90
• 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	16955739030266 [Primary]
GS1	26955739030263 [Package]; 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

[16955739030266]

Ethylene Oxide

[16955739030266]

Ethylene Oxide

[16955739030266]

Ethylene Oxide

[16955739030266]

Ethylene Oxide

[16955739030266]

Ethylene Oxide

[16955739030266]

Ethylene Oxide

[16955739030266]

Ethylene Oxide

[16955739030266]

Ethylene Oxide

[16955739030266]

Ethylene Oxide

[16955739030266]

Ethylene Oxide

[16955739030266]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-31
• Device Publish Date: 2018-12-31