Epoflier A.4086

GUDID 08033638801369

EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile.

SAPI MED SPA

Anoscope, single-use

• Primary Device ID: 08033638801369
• NIH Device Record Key: 426b75c8-b4e0-495e-a9f3-3fcf43db19f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epoflier
• Version Model Number: Surgical retractor
• Catalog Number: A.4086
• 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	08033638801352 [Primary]
GS1	08033638801369 [Package]; Contains: 08033638801352; 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: true
• Device Is Sterile: true

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

[08033638801369]

Ethylene Oxide

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

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