EBERLE

Basic Information

• Brand Name: EBERLE
• Primary DI: 04050052025755
• Version / Model: 9141320
• Catalog Number: 9141320
• Company Name: Eberle GmbH & Co. KG
• Labeler DUNS: 315919220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-23
• Public Version: 3
• Public Version Date: 2023-05-04
• Public Version Status: Update
• Public Device Record Key: d616b534-125a-4cd4-86f2-225b4f068817

Device Description

Aggressive Full Radius Resector 2,0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRX	Arthroscope	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38654	Arthroscopic shaver system blade, reusable	A cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04050052029685	GS1		5	In Commercial Distribution
Primary	04050052025755	GS1

Premarket Submissions

Submission Number	Supplement Number
K092977	000