EBERLE 9142742H

GUDID 04050052031015

Full Radius Resector Sharp Cut 4,2

Eberle GmbH & Co. KG

Arthroscopic shaver system blade, reusable

• Primary Device ID: 04050052031015
• NIH Device Record Key: 85f0d70b-1575-4cfa-b84a-39fcb6ee028f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EBERLE
• Version Model Number: 9142742H
• Catalog Number: 9142742H
• Company DUNS: 315919220
• Company Name: Eberle GmbH & Co. KG
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04050052021627 [Primary]
GS1	04050052031015 [Package]; Contains: 04050052021627; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092977

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-31
• Device Publish Date: 2018-06-30

On-Brand Devices [EBERLE]

• 04050052028831: Hammer
• 04050052028510: Removal Instrument Set
• 04050052027971: Immersion basket
• 04050052027919: Drill ø 9 mm
• 04050052027902: Curette for sampling
• 04050052027896: Tissue protection tube
• 04050052027889: Guid wire drill ø 3.2 mm
• 04050052027353: AO drill adapter
• 04050052031022: Round Burr 4,2-20°
• 04050052026998: Filling tube
• 04050052026981: Pusher
• 04050052026974: Introducer
• 04050052026950: Handle with locking pin
• 04050052030964: Aggressive Meniscus Cutter 4,8
• 04050052030896: Meniscus Cutter 5,5
• 04050052030919: Aggressive Full Radius Resector 4,8
• 04050052031046: Aggressive Oval Burr 6,5
• 04050052030018: Aggressive Oval Burr 6,5
• 04050052025779: Aggressive Full Radius Resector 5,5-15°gebogen
• 04050052030995: Oval Burr 6,5
• 04050052029685: Aggressive Full Radius Resector 2,0
• 04050052029555: .Full Radius Resector 2,0
• 04050052030872: Round Burr 6,5
• 04050052031039: Aggressive Oval Burr 5,5
• 04050052030926: Aggressive Full Radius Resector 5,5
• 04050052029999: Aggressive Full Radius Resector Plus 4,2
• 04050052029708: Aggressive Full Radius Resector 3,5
• 04050052029579: Full Radius Resector 3,5
• 04050052025151: Handpiece, manual operation, stainless steel
• 04050052025144: Handpiece, stainless steel
• 04050052030001: Aggressive Oval Burr 5,5
• 04050052024956: Endoscopic Camera System F1 HD
• 04050052024949: CMOS HD Camera Head with cable
• 04050052024925: Arthroscopy - Pump P2
• 04050052024611: Wire driver adapter, 0.6-1.8 mm
• 04050052024512: Light Source LED
• 04050052024505: Control unit F1 HD
• 04050052024314: Replacement Key (Sagittal Saw)
• 04050052023775: Drill chuck adapter 0.7-7.4 mm
• 04050052023508: Wire driver adapter, 1.8-3.2mm
• 04050052023492: Sagittal Saw, Quick Release
• 04050052023485: Sagittal saw adapter
• 04050052023478: Reamer, AO Synthes / ASIF / PROTEK
• 04050052023461: Drill chuck adapter, 0-3.0 mm, keyless
• 04050052023362: Drill chuck adapter, high-power, 0.7-7.4 mm
• 04050052022280: Handpiece, manual operation
• 04050052022006: Handpiece
• 04050052030933: Aggressive Full Radius Resector 4,2-15°gebogen
• 04050052030988: Oval Burr 5,5
• 04050052030865: Round Burr 5,5