ACE Medical

Basic Information

• Brand Name: ACE Medical
• Primary DI: 00840217905299
• Version / Model: ACESL10-20S
• Catalog Number: ACESL10-20S
• Company Name: Ebner Medical, LLC
• Labeler DUNS: 106135367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-09
• Public Version: 3
• Public Version Date: 2024-01-29
• Public Version Status: Update
• Public Device Record Key: 436a8e91-1595-4c83-8a8f-e0edbbe54f47

Device Description

Ceramic Kerrison Sublaminar Rongeur 10", 2mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAE	Rongeur, Manual	Neurology	882.4840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35541	Spinal rongeur	A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840217905299	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K200387	000

Device Sizes

Type	Value	Unit	Text
Length	10	Inch
Width	2	Millimeter