AZMED

GUDID 04717237118595

AZMED Night Splint (Black)

Whele LLC

Ankle/foot orthosis

• Primary Device ID: 04717237118595
• NIH Device Record Key: 582c1bb8-4549-4f78-b7f8-4c16ac4478f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AZMED
• Version Model Number: PXAZ-000004
• Company DUNS: 117947641
• Company Name: Whele LLC
• 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: 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	04717237118595 [Primary]

FDA Product Code

• ITW: Joint, Ankle, External Brace

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: 2025-04-23
• Device Publish Date: 2025-04-15