Anoscope A.4019

GUDID 08033638800034

Self-Light Diagnostic Proctoscope

SAPI MED SPA

Optical anoscope, single-use

• Primary Device ID: 08033638800034
• NIH Device Record Key: 3b817d38-2a9d-44cb-b059-05398ce11741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anoscope
• Version Model Number: A.4019
• Catalog Number: A.4019
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033638800027 [Primary]
GS1	08033638800034 [Package]; Contains: 08033638800027; Package: [75 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-17
• Device Publish Date: 2016-11-25

On-Brand Devices [Anoscope]

• 08033638800072: Self-Light Surgical Proctoscope
• 08033638800058: Self-Light Surgical Protoscope
• 08033638800034: Self-Light Diagnostic Proctoscope
• 08033638800003: Self-Light Diagnostic Proctoscope