Americare AMC-A7011

GUDID 26975424192014

Probe Cover, PE, Gel and Elastic bands 15x122cm, 6"x48"

EXACT MEDICAL MANUFACTURING, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 26975424192014
• NIH Device Record Key: 2912254c-c169-4007-a00c-52c841491bfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Americare
• Version Model Number: AMC-A7011
• Catalog Number: AMC-A7011
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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	06975424192010 [Primary]
GS1	26975424192014 [Package]; Contains: 06975424192010; Package: Case [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211969

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2023-04-13
• Device Publish Date: 2023-04-05

On-Brand Devices [Americare]

• 26975424192069: Probe Cover, VIP Film, Gel, El.Bands, Cardb. 15x244cm-6"x96"
• 26975424192052: Probe Cover, PE, Gel and Elastic bands 15x244cm, 6"x96"
• 26975424192045: Microscope Drape, Leica, Bayonet, 137x381cm -54"x150"
• 26975424192038: Microscope Drape, Leica, Bayonet, 137x305cm - 54"x120"
• 26975424192021: Back Table Cover Reinforced 44" x 75"
• 26975424192014: Probe Cover, PE, Gel and Elastic bands 15x122cm, 6"x48"
• 26975424192007: Probe Cover, VIP film, Gel, El.b, Cardb. 15x122cm - 6"x48"
• 26975424191994: Cover, Mayo Stand 23" x 54", Sterile
• 26975424191987: Microscope Drape- Zeiss MD, 137x381cm - 54"x150"