Pack of 1000 pcs. disposable ear specula Ø 5 mm, 10803-535

GUDID 04045396147539

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: 04045396147539
• NIH Device Record Key: 204c8ee7-299c-4605-aa9d-ea949890dff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pack of 1000 pcs. disposable ear specula Ø 5 mm,
• Version Model Number: 10803-535
• Catalog Number: 10803-535
• 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	04045396147539 [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 of 1000 pcs. disposable ear specula Ø 5 mm,]

• 04045396147539: With the Riester ear specula in combination with a Riester otoscope, the auditory canal is illum
• 04045396147331: With the Riester ear specula in combination with a Riester otoscope, the auditory canal is illum