Self-light anoscopes A.4019L

GUDID 08033638802892

SELF-LED-LIGHT - Diagnostic/paediatric trunk-end proctoscope with built-in LED light. Disposable. Tube length 54mm. Tube diameter 18mm.

SAPI MED SPA

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• Primary Device ID: 08033638802892
• NIH Device Record Key: 6daf9866-54b2-4540-aef6-570c3e6c1524
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Self-light anoscopes
• Version Model Number: Diagnostic Self-Led-Light
• Catalog Number: A.4019L
• 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	08033638802885 [Primary]
GS1	08033638802892 [Package]; Contains: 08033638802885; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070913

FDA Product Code

• FER: Anoscope And Accessories

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 [Self-light anoscopes]

• 08033638802892: SELF-LED-LIGHT - Diagnostic/paediatric trunk-end proctoscope with built-in LED light. Disposable
• 08033638801260: SELF-LED-LIGHT - Surgical/Examination trunk-end proctoscope with built-in LED light. Disposable.
• 08033638803585: SELF-LED-LIGHT - Surgical/Examination flute beaked proctoscope with built-in LED light. Disposab
• 08033638800447: SELF-LIGHT SCOPE - Surgical/Examination trunk ended proctoscope. Disposable. Tube length 79mm.