M00591000

GUDID 16926839812304

Clip

Anrei Medical(HZ) Co.,Ltd.

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

• Primary Device ID: 16926839812304
• NIH Device Record Key: 2f705d3a-6449-417b-b866-f345f7752a75
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: M00591000
• Catalog Number: M00591000
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16926839812304 [Primary]
GS1	26926839812318 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	26926839812325 [Package]; Package: [20 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-12-11
• Device Publish Date: 2025-10-27

Devices Manufactured by Anrei Medical(HZ) Co.,Ltd.

• 16926839812304 - NA: 2025-12-11Clip
• 16926839812304 - NA: 2025-12-11 Clip
• 26926839812349 - NA: 2025-12-11 Clip
• 26926839812370 - NA: 2025-12-11 Single-Use Snare
• 26926839812400 - NA: 2025-12-11 Single-Use Snare
• 26926839812431 - NA: 2025-12-11 Single-Use Snare
• 26926839812462 - NA: 2025-12-11 Single-Use Snare
• 26926839812493 - NA: 2025-12-11 Single-Use Snare
• 26926839812523 - NA: 2025-12-11 Single-Use Snare