Rectoscope A.4113

GUDID 08033638800171

Proctoscope 130 mm

SAPI MED SPA

Optical proctoscope, single-use

• Primary Device ID: 08033638800171
• NIH Device Record Key: 50f9dfcb-7dd1-4756-a430-c7fdc001db3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rectoscope
• Version Model Number: A.4113
• Catalog Number: A.4113
• 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	08033638800164 [Primary]
GS1	08033638800171 [Package]; Contains: 08033638800164; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070915

FDA Product Code

• KDM: Sigmoidoscope, Rigid, Non-Electrical

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 [Rectoscope]

• 08033638800270: Multi-purpose rectoscope
• 08033638800256: MPR short multi-purpose rectoscope
• 08033638800218: Rectoscope 250 mm
• 08033638800195: Pediatric rectoscope 200 mm
• 08033638800171: Proctoscope 130 mm