Amtouch Aligner Chewies AMAC-PU

GUDID 00850058951362

Aligner Chewies - Unscented - Purple (20/pk)

AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.

Orthodontic aligner/retainer seater, single-use

• Primary Device ID: 00850058951362
• NIH Device Record Key: 46dd07b1-e85e-4229-8932-86e7460773d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amtouch Aligner Chewies
• Version Model Number: Unscented - Purple
• Catalog Number: AMAC-PU
• Company DUNS: 180611519
• Company Name: AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850058951362 [Primary]

FDA Product Code

• ECS: Pusher, Band, Orthodontic

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: 2024-10-16
• Device Publish Date: 2024-10-08

On-Brand Devices [Amtouch Aligner Chewies]

• 00850058951379: Aligner Chewies - Unscented - White (20/pk)
• 00850058951362: Aligner Chewies - Unscented - Purple (20/pk)