FDA UDI
In Commercial Distribution
🇺🇸 United States
Transit-Pellets
DI: 07350099550010
·
Model: Radiopaque Markers
·
Medifactia AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Transit-Pellets
- Primary DI
- 07350099550010
- Version / Model
- Radiopaque Markers
- Company Name
- Medifactia AB
- Labeler DUNS
- 352375622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-09
- Public Version
- 4
- Public Version Date
- 2024-04-15
- Public Version Status
- Update
- Public Device Record Key
- 5c22f980-16ea-4440-93fe-1bf6df10434a
Device Description
Transit-Pellets radiopaque markers.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | Gastroenterology, Urology | 876.1725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36115 | Radiological image marker, ingestible | A device intended to be orally introduced for ingestion to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a capsule used to locate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray or nuclear medicine]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350099550010 | GS1 |
Customer Contacts
- Phone
- +46 846007206
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Stored at normal room temperature