FDA UDI
In Commercial Distribution
🇺🇸 United States
imagiQ
DI: 07332339242473
·
Model: imagiQ3 Legacy
·
Stille AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- imagiQ
- Primary DI
- 07332339242473
- Version / Model
- imagiQ3 Legacy
- Catalog Number
- 550-1702
- Company Name
- Stille AB
- Labeler DUNS
- 355280827
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-04
- Public Version
- 1
- Public Version Date
- 2024-11-12
- Public Version Status
- New
- Public Device Record Key
- 7c3b5e24-53cb-4d48-a58d-0ee5af72a582
Device Description
TABLE, OPERATINGROOM, ELECTRICAL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDC | Table, Operating-Room, Electrical | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40658 | Fluoroscopy/angiography table, powered | A powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07332339242473 | GS1 |
Customer Contacts
- Phone
- +46858858000
- [email protected]