FDA UDI
In Commercial Distribution
🇺🇸 United States
GIOTTO IMAGE 3DL
DI: 08033837190059
·
Model: GIOTTO IMAGE_21'' 2Mpixel
·
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GIOTTO IMAGE 3DL
- Primary DI
- 08033837190059
- Version / Model
- GIOTTO IMAGE_21'' 2Mpixel
- Catalog Number
- 6902
- Company Name
- I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
- Labeler DUNS
- 429113525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 18d4be82-20a3-4eea-88f3-6233dde056cf
Device Description
GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| MUE | Full Field Digital,System,X-Ray,Mammographic | Radiology | 892.1715 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36513 | Mammographic x-ray system stereotactic unit | A device that can only fulfil its purpose when used together with and enhance the function of a diagnostic mammographic x-ray system. It is used to take two pictures of a breast from two different angles. On the basis of this stereoscopic picture set, it is possible to determine the exact position of a lesion in the breast and a cytological sample of this will be taken. This device or technique may be built-in to some diagnostic x-ray systems for mammography. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033837190059 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111434 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 2240 | Millimeter | |
| Depth | 1140 | Millimeter | |
| Width | 1150 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius