Transit-Pellets

GUDID 07350099550010

Transit-Pellets radiopaque markers.

Medifactia AB

Imaging lesion localization marker, ingestible
Primary Device ID07350099550010
NIH Device Record Key5c22f980-16ea-4440-93fe-1bf6df10434a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransit-Pellets
Version Model NumberRadiopaque Markers
Company DUNS352375622
Company NameMedifactia AB
Device Count1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com
Phone+46 846007206
Emailinfo@medifactia.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Stored at normal room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS107350099550010 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-04-04
Device Publish Date2019-10-09
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