LEM A.5661

GUDID 08033638801680

LEM - Disposable haemorrhoid banding ligator for use with forceps - complete with rings loader.

SAPI MED SPA

Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator Haemorrhoid ligator

• Primary Device ID: 08033638801680
• NIH Device Record Key: f93bd0ec-dfd8-43fd-a2f3-42f0b923568a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEM
• Version Model Number: Traction LEM with rind loader
• Catalog Number: A.5661
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033638801673 [Primary]
GS1	08033638801680 [Package]; Contains: 08033638801673; 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.