Amtouch Barrier Envelopes AMBE-0

GUDID 00850058951386

Barrier Envelopes, Top Open, Size #0 (100/Box)

AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.

X-ray film cassette, manual

• Primary Device ID: 00850058951386
• NIH Device Record Key: bfe403ae-da31-4806-a43f-9df6bf6d665d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amtouch Barrier Envelopes
• Version Model Number: Top Open - Size 0
• Catalog Number: AMBE-0
• Company DUNS: 180611519
• Company Name: AMERICAN MEDICAL & HOSPITAL SUPPLY CO., 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: false
• Device Combination Product: false
• Single Use: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850058951386 [Primary]

FDA Product Code

• PEM: Dental Barriers And Sleeves

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 Barrier Envelopes]

• 00850058951423: Barrier Envelopes, Top Open, Size #4 (50/Box)
• 00850058951416: Barrier Envelopes, Top Open, Size #3 (100/Box)
• 00850058951409: Barrier Envelopes, Top Open, Size #2 (100/Box)
• 00850058951393: Barrier Envelopes, Top Open, Size #1 (100/Box)
• 00850058951386: Barrier Envelopes, Top Open, Size #0 (100/Box)