Sitzmarks Radiopaque Markers

GUDID 00610858081085

KONSYL PHARMACEUTICALS, INC.

Gastrointestinal telemetric monitoring system capsule, non-sterile
Primary Device ID00610858081085
NIH Device Record Keyd985e487-7a91-4d9a-a345-46efd6d16b28
Commercial Distribution StatusIn Commercial Distribution
Brand NameSitzmarks Radiopaque Markers
Version Model NumberDouble D
Company DUNS102463866
Company NameKONSYL PHARMACEUTICALS, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100610858081085 [Primary]
GS130610858081115 [Unit of Use]
GS130610858081116 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFXSystem, Gastrointestinal Motility (Electrical)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-23
Device Publish Date2018-06-22

On-Brand Devices [Sitzmarks Radiopaque Markers]

00610858081306Combo Pak
00610858081139Combo Pak
00610858081122Tri-Chamber
00610858081115Double D
00610858081108Round Hollow
00610858081092Tri-Chamber
00610858081085Double D
00610858081078Round Hollow
00610858081023Tri-Chamber
00610858081016Double D
00610858081009Round Hollow

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