Rectoscope equipment A.4525LINS

GUDID 08033638800720

Non sterile and disposable equipment made of 250mm rectoscope, grip, insufflator and built-in LED light.

SAPI MED SPA

Proctoscope, single-use

• Primary Device ID: 08033638800720
• NIH Device Record Key: 407f8cfe-541c-4ae9-b2be-2b38f5339040
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rectoscope equipment
• Version Model Number: Rectoscope equipment with LED
• Catalog Number: A.4525LINS
• 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	08033638800713 [Primary]
GS1	08033638800720 [Package]; Contains: 08033638800713; Package: [20 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [Rectoscope equipment]

• 08033638801567: Non sterile and disposable equipment made of 250mm rectoscope, grip and insufflator.
• 08033638800720: Non sterile and disposable equipment made of 250mm rectoscope, grip, insufflator and built-in LE