Anrei

GUDID 06948318912315

Anrei Medical(HZ) Co.,Ltd.

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

• Primary Device ID: 06948318912315
• NIH Device Record Key: ac23ef7d-5900-4aa3-b065-c24680002f2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anrei
• Version Model Number: HG-II-5CVM
• Company DUNS: 529128653
• Company Name: Anrei Medical(HZ) Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948318912315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201771

FDA Product Code

• PKL: Hemostatic Metal Clip For The Gi Tract

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-09
• Device Publish Date: 2020-11-01

On-Brand Devices [Anrei]

• 06948318912346: HG-VII-5CVM
• 06948318912339: HG-V-2CVM
• 06948318912322: HG-III-2CVM
• 06948318912315: HG-II-5CVM
• 06948318912308: HG-VII-2C
• 06948318912292: HG-III-2C
• 06948318912285: HG-V-2C
• 06948318912278: HG-II-2C
• 26948318968828: M00515101
• 16948318903921: M00515100