VIDEO SIGMOIDOSCOPE

GUDID 04961333232635

VIDEO SIGMOIDOSCOPES (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible video gastroscope Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable Flexible video gastroscope, reusable

Primary Device ID	04961333232635
NIH Device Record Key	35ba7133-c451-40c0-a717-97bf10baa685
Commercial Distribution Discontinuation	2017-04-06
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	VIDEO SIGMOIDOSCOPE
Version Model Number	ES-3830K
Company DUNS	083211284
Company Name	PENTAX OF AMERICA, INC.
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	false
Serial Number	true
Manufacturing Date	false
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	04961333232635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K951577

FDA Product Code

FAM	Sigmoidoscope And Accessories, Flexible/Rigid