FDA UDI
In Commercial Distribution
🇺🇸 United States
CALLISTO eye Panel PC
DI: 04049539103512
·
Model: Model II
·
Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CALLISTO eye Panel PC
- Primary DI
- 04049539103512
- Version / Model
- Model II
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 342228620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-22
- Public Version
- 4
- Public Version Date
- 2020-08-20
- Public Version Status
- Update
- Public Device Record Key
- 330f36af-7125-4f72-b2f3-b9ac6ad5973b
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 |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38452 | Desktop computer | A non-dedicated, electrically-powered computer designed to be stationary on a desk or other work platform. It typically includes a microprocessor [central processing unit (CPU)], a monitor, and a keyboard/mouse. When used with dedicated software the computer may function as a medical device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049539103512 | GS1 |