DoseRite DR-AIN01-US

GUDID 00850000610118

DoseRite Anal Applicator Pack

SURGIN SURGICAL INSTRUMENTATION, INC.

Rectal medication applicator, reusable

• Primary Device ID: 00850000610118
• NIH Device Record Key: f6bd909b-d45e-4d16-8eb5-3d4302a58a4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DoseRite
• Version Model Number: DR-AIN01-US
• Catalog Number: DR-AIN01-US
• Company DUNS: 076656164
• Company Name: SURGIN SURGICAL INSTRUMENTATION, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000610118 [Primary]

FDA Product Code

• KYZ: Syringe, Irrigating (Non Dental)

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: 2023-07-18
• Device Publish Date: 2023-07-10

On-Brand Devices [DoseRite]

• 00850000610118: DoseRite Anal Applicator Pack
• 00850000610064: DoseRite Anal Fissure Pack, Metric
• 00850000610033: DoseRite Reusable Pack, Metric
• 00850000610026: DoseRite Reusable Pack (Case of 10)
• 00850000610002: DoseRite Anal Fissure Pack, Reusable, Metric