1077 Accessory Box AB07 101327

GUDID 04260223146022

Accessory box Content: 1. Transparent Lurex Box 11 compartments. AN100336 2. Probe Tip 'Adult' for Children & Adults. AN100013 3. Ear tip ET-03 5 mm. AN100063 4. Ear tip Lamella 6-10mm, blue. AN100064 5. Ear Tip, Lamella 8-11mm. AN100144 6. Ear tip ET-11 Lamella 12-16mm. AN100125 7. EarTip Soft ET-16 10mm. AN100838 8. Ear tip Soft ET-17 14 mm. AN100839 9. Inspection tool. AN101326

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223146022
• NIH Device Record Key: 7bbac510-59a7-48d6-b120-dc1cc405f56c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1077 Accessory Box AB07
• Version Model Number: 8-69-41350
• Catalog Number: 101327
• Company DUNS: 551540334
• Company Name: PATH medical GmbH
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260223146022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100661

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2022-01-25
• Device Publish Date: 2022-01-17

Devices Manufactured by PATH medical GmbH

• 04260223142994 - Sentiero Desktop Diagnostic: 2024-05-30 Sentiero Desktop Set Diagnostic Content: 1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG 2. USB data cable AN100418 3. Probe E
• 04260223147210 - Ear Tip PM009H Pack/100 pcs.: 2024-05-30 9 mm mushroom ear tip, hard version
• 04260223147227 - Ear Tip PM010H Pack/100 pcs.: 2024-05-30 10 mm mushroom ear tip, hard version
• 04260223146572 - Ear Tip ET-LT40G Pack/100 pcs.: 2023-11-22
• 04260223146596 - Ear Tip ET-LT45G Pack/100 pcs.: 2023-11-22
• 04260223146619 - Ear Tip ET-LT50G Pack/100 pcs.: 2023-11-22
• 04260223146633 - Ear Tip ET-LT60M Pack/100 pcs.: 2023-11-22
• 04260223146978 - Ear Tip PM007H Pack/100 pcs.: 2023-11-22 7 mm mushroom ear tip, hard version