FDA UDI
In Commercial Distribution
🇺🇸 United States
MyoSPECT ES
DI: 00195278488626
·
Model: H3912BD
·
G E MEDICAL SYSTEMS ISRAEL LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MyoSPECT ES
- Primary DI
- 00195278488626
- Version / Model
- H3912BD
- Catalog Number
- 5875815-40
- Company Name
- G E MEDICAL SYSTEMS ISRAEL LTD.
- Labeler DUNS
- 532102365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-14
- Public Version
- 1
- Public Version Date
- 2023-09-22
- Public Version Status
- New
- Public Device Record Key
- 85be9c17-9f84-4726-bef7-fe24ba6e7a33
Device Description
MyoSPECT ES MDR GANTRY
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
- Yes
- 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 |
|---|---|---|---|---|
| KPS | System, tomography, computed, emission | Radiology | 892.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40640 | Stationary gamma camera system | An assembly of static diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, crystal(s), a collimator and a set of photomultiplier tubes or photo diodes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195278488626 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212004 | 000 |