FDA UDI
In Commercial Distribution
🇺🇸 United States
Eckert & Ziegler Isotope Products, Inc.
DI: 00810117210274
·
Model: A3407-4
·
Eckert & Ziegler Isotope Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Eckert & Ziegler Isotope Products, Inc.
- Primary DI
- 00810117210274
- Version / Model
- A3407-4
- Company Name
- Eckert & Ziegler Isotope Products, Inc.
- Labeler DUNS
- 041668633
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- c20966c0-2bfc-41ee-aeb3-e8a2d15d6530
Device Description
Quality Assurance Line Source
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
- No
- 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 |
|---|---|---|---|---|
| IXD | Source, Calibration, Sealed, Nuclear | Radiology | 892.1400 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40608 | Nuclear medicine phantom, line source | A device which is either a linear radioactive sealed source or refillable linear radiolucent tube to which radioactivity can be added. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of photon detector systems used in nuclear medicine imaging applications and associated image acquisition, display and analysis computer programs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810117210274 | GS1 |