Amsco Eagle RE43

GUDID 00724995151829

Amsco Eagle 3000 Medium Sterilizers are designed for sterilization of certain materials used in healthcare facilities.

Steris Mexico, S. de R.L. de C.V.

Steam sterilizer

• Primary Device ID: 00724995151829
• NIH Device Record Key: 15713c31-56b3-4285-9b40-e6ec0592cac6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amsco Eagle
• Version Model Number: 3043
• Catalog Number: RE43
• Company DUNS: 813116209
• Company Name: Steris Mexico, S. de R.L. de C.V.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995151829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964332

FDA Product Code

• FLE: Sterilizer, steam

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-20
• Device Publish Date: 2016-09-14

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