Pack with 1000 pcs., 40x25 pieces in polybag 14066-534

GUDID 04045396916937

With the Riester ear specula in combination with a Riester otoscope, the auditory canal is illuminated and examined.

Rudolf Riester GmbH

Ear speculum, reusable

• Primary Device ID: 04045396916937
• NIH Device Record Key: af664922-c568-4da8-b64a-3991bc41b44d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pack with 1000 pcs., 40x25 pieces in polybag
• Version Model Number: 14066-534
• Catalog Number: 14066-534
• Company DUNS: 537208717
• Company Name: Rudolf Riester 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04045396916937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932506

FDA Product Code

• EPY: Speculum, Ent

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: 2021-02-05
• Device Publish Date: 2021-01-28

On-Brand Devices [Pack with 1000 pcs., 40x25 pieces in polybag]

• 04045396916937: With the Riester ear specula in combination with a Riester otoscope, the auditory canal is illum
• 04045396916920: With the Riester ear specula in combination with a Riester otoscope, the auditory canal is illum