Hemoclip SCA-23-230-09

GUDID 06936603218235

Hemoclip rotatable; PTFE coating, repositionable; tube 2,5mm, length 230cm, 9mm clip length

Yangzhou Fartley Medical Instrument Technology Co., Ltd

Gastrointestinal endoscopic clip, long-term, non-bioabsorbable

• Primary Device ID: 06936603218235
• NIH Device Record Key: fa8b8dcf-52ee-4b41-a916-1bd5e6d54adb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemoclip
• Version Model Number: FTL-HC-9-230-O
• Catalog Number: SCA-23-230-09
• Company DUNS: 544375774
• Company Name: Yangzhou Fartley Medical Instrument Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	06936603218235 [Primary]
GS1	16936603218232 [Package]; Package: Sales Packaging [10 Units]; In Commercial Distribution
GS1	26936603218239 [Package]; Contains: 16936603218232; Package: Shipping Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230004

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: 2024-10-28
• Device Publish Date: 2024-10-18

On-Brand Devices [Hemoclip]

• 06936603227930: Hemoclip rotatable; PTFE coating, repositionable; tube 2,5mm, length 180cm, 16mm clip length
• 06936603227923: Hemoclip rotatable; PTFE coating, repositionable; tube 2,5mm, length 180cm, 12mm clip length
• 06936603227916: Hemoclip rotatable; PTFE coating, repositionable; tube 2,5mm, length 180cm, 9mm clip length
• 06936603226674: FTL-HC-16-230-O
• 06936603218235: Hemoclip rotatable; PTFE coating, repositionable; tube 2,5mm, length 230cm, 9mm clip length
• 06936603218228: Hemoclip rotatable; PTFE coating, repositionable; tube 2,5mm, length 230cm, 16mm clip length
• 06936603218211: Hemoclip rotatable; PTFE coating, repositionable; tube 2,5mm, length 230cm, 12mm clip length