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

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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