AMSure® EAR/ULCER SYRINGE AS00501

GUDID 10704411008316

AMSure® EAR/ULCER SYRINGE 1 oz. Bulk

AMSINO INTERNATIONAL, INC.

Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe Ear canal irrigation syringe

• Primary Device ID: 10704411008316
• NIH Device Record Key: 0a2c38d4-4668-4a54-be1c-2cacad502cdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® EAR/ULCER SYRINGE
• Version Model Number: 1
• Catalog Number: AS00501
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• Device Count: 300
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411008316 [Primary]
GS1	40704411008317 [Unit of Use]

FDA Product Code

• KYZ: Syringe, Irrigating (Non Dental)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-21
• Device Publish Date: 2018-06-05

On-Brand Devices [AMSure® EAR/ULCER SYRINGE]

• 40704411008362: AMSure® EAR/ULCER SYRINGE 3 oz
• 40704411008355: AMSure® EAR/ULCER SYRINGE 2 oz
• 40704411008348: AMSure® EAR/ULCER SYRINGE 1 oz
• 10704411008330: AMSure® EAR/ULCER SYRINGE 3 oz. Bulk
• 10704411008323: AMSure® EAR/ULCER SYRINGE 2 oz. Bulk
• 10704411008316: AMSure® EAR/ULCER SYRINGE 1 oz. Bulk