FDA.reportPublic FDA data

Sitzmarks Radiopaque Markers

Primary DI
00610858081306
Brand
Sitzmarks Radiopaque Markers
Company
Konsyl Pharmaceuticals, Inc.
Model
Combo Pak
Published
2018-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FFXSystem, Gastrointestinal Motility (Electrical)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K881609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881609000SITZMARKSLafayette Pharmacal, Inc.1988-07-08FFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00610858081306PrimaryGS10
30610858081130Unit of UseGS10
30610858081139Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610858081306006108580813066108580813060610858081306
3061085808113030610858081130
3061085808113930610858081139

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring system capsule, non-sterileA non-sterile, battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless transmission of one or more gastrointestinal parameter signals (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
102463866
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610858081078Sitzmarks Radiopaque MarkersRound Hollow2018-06-22
00610858081085Sitzmarks Radiopaque MarkersDouble D2018-06-22
00610858081092Sitzmarks Radiopaque MarkersTri-Chamber2018-06-22
00610858081108Sitzmarks Radiopaque MarkersRound Hollow2017-12-11
00610858081115Sitzmarks Radiopaque MarkersDouble D2017-12-11
00610858081122Sitzmarks Radiopaque MarkersTri-Chamber2017-12-11
00610858081139Sitzmarks Radiopaque MarkersCombo Pak2018-06-22
10610858081006Sitzmarks Radiopaque MarkersRound Hollow2017-02-17
10610858081013Sitzmarks Radiopaque MarkersDouble D2017-02-17
10610858081020Sitzmarks Radiopaque MarkersTri-Chamber2017-02-17
00610858081009Sitzmarks Radiopaque MarkersRound Hollow2017-11-03
00610858081016Sitzmarks Radiopaque MarkersDouble D2017-11-03
00610858081023Sitzmarks Radiopaque MarkersTri-Chamber2017-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10678467508437Mui ScientificH & A Mui Enterprises IncFFX2026-04-15
10678467508413Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00678467508416Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00851607003501mcompass Anorectal Balloon Expulsion CatheterMEDSPIRA, LLCFFX2025-12-30
00678467508393Mui ScientificH & A Mui Enterprises IncFFX2025-11-04
00678467508386Mui ScientificH & A Mui Enterprises IncFFX2025-10-21
00678467508362Mui ScientificH & A Mui Enterprises IncFFX2025-09-15
10678467508352Mui ScientificH & A Mui Enterprises IncFFX2025-08-28
00678467508355Mui ScientificH & A Mui Enterprises IncFFX2025-08-28
10678467508345Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
00678467508348Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
10678467508338Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
00678467508331Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
10884521855441ManoScanGiven Imaging, Inc.FFX2025-08-21
10678467508307Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508314Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
00678467508300Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
00678467508317Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508109Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
10678467508291Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508102Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508294Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508270Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00678467508287Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00816734023433Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023440Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023457Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023464Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023471Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023488Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16