Retractor A.4083

GUDID 08033638800133

The Beak Surgical proctoscope

SAPI MED SPA

Optical anoscope, single-use

• Primary Device ID: 08033638800133
• NIH Device Record Key: 55bb443f-6d5e-4e88-a013-58285b0ee9cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retractor
• Version Model Number: A.4083
• Catalog Number: A.4083
• 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	08033638800126 [Primary]
GS1	08033638800133 [Package]; Contains: 08033638800126; 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

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

[08033638800133]

Ethylene Oxide

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 [Retractor]

• 08033638800157: The Beak Diagnostic
• 08033638800133: The Beak Surgical proctoscope
• 08033638800119: Basile's conical anal retractor
• 08033638800096: Anal retractor