LEM A.5650.3

GUDID 08033638802335

LEM - Disposable haemorrhoid banding ligator for use with suction complete with 3 latex bands.

SAPI MED SPA

Haemorrhoid ligator

• Primary Device ID: 08033638802335
• NIH Device Record Key: e26e9ddd-64e8-46f7-8d03-afe1d16eb3f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEM
• Version Model Number: Suction LEM with bands
• Catalog Number: A.5650.3
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033638802328 [Primary]
GS1	08033638802335 [Package]; Contains: 08033638802328; 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: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [LEM]

• 08033638802335: LEM - Disposable haemorrhoid banding ligator for use with suction complete with 3 latex bands.
• 08033638801680: LEM - Disposable haemorrhoid banding ligator for use with forceps - complete with rings loader.