Pen LED B.0306

GUDID 08033638801055

Pen-LED-light for Sapi Med anoscopes, rectoscopes and retractors.

SAPI MED SPA

Endoscopic light source unit, battery-powered

• Primary Device ID: 08033638801055
• NIH Device Record Key: 180b9d05-2b10-4a8d-873e-18d03353f1d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pen LED
• Version Model Number: Pen LED light
• Catalog Number: B.0306
• Company DUNS: 437320088
• Company Name: SAPI MED SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	08033638801048 [Primary]
GS1	08033638801055 [Package]; Contains: 08033638801048; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• NTN: Led Light Source

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: 2023-08-10
• Device Publish Date: 2023-08-02

Devices Manufactured by SAPI MED SPA

• 08033638800621 - Rectoscope equipment: 2025-02-25 Non-sterile and disposable rectoscope equipment of 17mm diameter with insufflator and built-in LED light.
• 08033638801536 - Rectoscope equipment: 2025-02-25 Non-sterile and disposable rectoscope equipment of 12,5mm diameter with insufflator and built-in LED light.
• 08033638800003 - Anoscope: 2023-11-17 Self-Light Diagnostic Proctoscope
• 08033638800034 - Anoscope: 2023-11-17 Self-Light Diagnostic Proctoscope
• 08033638800058 - Anoscope: 2023-11-17 Self-Light Surgical Protoscope
• 08033638800072 - Anoscope: 2023-11-17 Self-Light Surgical Proctoscope
• 08033638800096 - Retractor: 2023-11-17 Anal retractor
• 08033638800119 - Retractor: 2023-11-17 Basile's conical anal retractor