AMSure®HG Hydrophilic Intermittent Urethral Catheter HG971616SS

GUDID 40704411008898

AMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 16Fr

AMSINO INTERNATIONAL, INC.

Intermittent urethral drainage catheter, non-antimicrobial, single-use

• Primary Device ID: 40704411008898
• NIH Device Record Key: 0170f1f4-5734-4092-b6ea-4e17999a0e3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure®HG Hydrophilic Intermittent Urethral Catheter
• Version Model Number: 1
• Catalog Number: HG971616SS
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• 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: 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	10704411008897 [Primary]
GS1	40704411008898 [Package]; Contains: 10704411008897; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• EZD: Catheter, Straight

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-10
• Device Publish Date: 2025-07-02

On-Brand Devices [AMSure®HG Hydrophilic Intermittent Urethral Catheter]

• 40704411008898: AMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 16Fr
• 40704411008881: AMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 14Fr
• 40704411008874: AMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 12Fr
• 10704411008866: AMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 10Fr