Self-Suction-LEM A.5670

GUDID 08033638801727

Self-Suction-LEM - Single-patient device for suction band ligation of hemorrhoids and no need for an external surgical aspirator.

SAPI MED SPA

Haemorrhoid ligation set

• Primary Device ID: 08033638801727
• NIH Device Record Key: fa67550c-5da7-42bb-a0b0-c57e09fb49b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Self-Suction-LEM
• Version Model Number: Self-Suction-LEM
• Catalog Number: A.5670
• Company DUNS: 437320088
• Company Name: SAPI MED SPA
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033638801710 [Primary]
GS1	08033638801727 [Package]; Contains: 08033638801710; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070881

FDA Product Code

• FHN: Ligator, Hemorrhoidal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-16
• Device Publish Date: 2026-02-06

On-Brand Devices [Self-Suction-LEM]

• 08033638803318: SELF-SUCTION LEM - Disposable haemorrhoid banding ligator with auto suction. Complete with 3 ban
• 08033638801727: Self-Suction-LEM - Single-patient device for suction band ligation of hemorrhoids and no need fo