ETHACE14S

GUDID 10888551010092

HARMONIC ACE CURVED SHEARS W/SCISSOR HANDLE & HAND CONTROL 15MM ACTIVE BLADE

STERILMED, INC.

Soft-tissue ultrasonic surgical system holder/tip, reprocessed Soft-tissue ultrasonic surgical system holder/tip, reprocessed

• Primary Device ID: 10888551010092
• NIH Device Record Key: d439597c-4563-49f5-85c2-4bbe66427588
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ETHACE14S
• Catalog Number: ETHACE14S
• Company DUNS: 175899459
• Company Name: STERILMED, INC.
• 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: 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

Customer Support Contacts

• Phone: +1(888)541-0078
• Email: customerservice@sterilmed.com
• Phone: +1(888)541-0078
• Email: customerservice@sterilmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888551010092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050343

FDA Product Code

• NLQ: Scalpel, ultrasonic, reprocessed

Sterilization

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

[10888551010092]

Ethylene Oxide

[10888551010092]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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• 10888551045209 - NA: 2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
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• 10888551000048 - NA: 2020-11-06 CTS RELIEF KIT, 5PC SET
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