Transit-Pellets

GUDID 07350099550010

Transit-Pellets radiopaque markers.

Medifactia AB

Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Imaging lesion localization marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible

• Primary Device ID: 07350099550010
• NIH Device Record Key: 5c22f980-16ea-4440-93fe-1bf6df10434a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transit-Pellets
• Version Model Number: Radiopaque Markers
• Company DUNS: 352375622
• Company Name: Medifactia AB
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com
• Phone: +46 846007206
• Email: info@medifactia.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored at normal room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350099550010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181760

FDA Product Code

• FFX: System, Gastrointestinal Motility (Electrical)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-04
• Device Publish Date: 2019-10-09