FDA UDI
In Commercial Distribution
🇺🇸 United States
GIOTTO CLASS
DI: 08056977360014
·
Model: GIOTTO CLASS 3D READY
·
IMS GIOTTO SPA
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- GIOTTO CLASS
- Primary DI
- 08056977360014
- Version / Model
- GIOTTO CLASS 3D READY
- Catalog Number
- 30010-yy
- Company Name
- IMS GIOTTO SPA
- Labeler DUNS
- 437701793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-23
- Public Version
- 1
- Public Version Date
- 2021-03-31
- Public Version Status
- New
- Public Device Record Key
- 29df0394-aa3a-4380-b2ba-c0ad548c1bf7
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 |
|---|---|---|---|---|
| 37672 | Stationary mammographic x-ray system, digital | A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18056977360011 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 08056977360014 | GS1 | ||||
| Package | 28056977360018 | GS1 | 1 | In Commercial Distribution | ||
| Package | 38056977360015 | GS1 | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200424 | 000 |