ACE+ HAR23R

GUDID 10888551045100

Reprocessed Harmonic ACE® 5 mm Diameter Shears + ADAPTIVE TISSUE TECHNOLOGY, 5mm x 23cm

STERILMED, INC.

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

• Primary Device ID: 10888551045100
• NIH Device Record Key: 8b0b6c11-bd53-41d6-9489-7705e35860de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE+
• Version Model Number: HAR23R
• Catalog Number: HAR23R
• 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	10888551045100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161086

FDA Product Code

• NUJ: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED

Sterilization

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

[10888551045100]

Ethylene Oxide

[10888551045100]

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: 2017-04-17

On-Brand Devices [ACE+]

• 10888551045117: Reprocessed Harmonic ACE® 5 mm Diameter Shears + ADAPTIVE TISSUE TECHNOLOGY, 5mm x 36cm
• 10888551045100: Reprocessed Harmonic ACE® 5 mm Diameter Shears + ADAPTIVE TISSUE TECHNOLOGY, 5mm x 23cm