Dilatan Plus A.1002

GUDID 08033638803943

SAPI MED SPA

Rectal dilator, reusable

• Primary Device ID: 08033638803943
• NIH Device Record Key: 58b73fe1-bdc2-4c4a-9c64-8b52ada002eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dilatan Plus
• Version Model Number: Dilators 23/27 mm diameter
• Catalog Number: A.1002
• Company DUNS: 437320088
• Company Name: SAPI MED SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	08033638800355 [Primary]
GS1	08033638803943 [Package]; Contains: 08033638800355; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• FFP: Dilator, Rectal

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 [Dilatan Plus]

• 08033638803950: 30 mm diameter Dilator
• 08033638803943: Dilators 23/27 mm diameter
• 08033638800348: Dilators 18/20 mm diameter