FDA UDI
In Commercial Distribution
🇺🇸 United States
Rando®
DI: 00812266030932
·
Model: XA235L
·
Providus Holdings, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Rando®
- Primary DI
- 00812266030932
- Version / Model
- XA235L
- Catalog Number
- XA235L
- Company Name
- Providus Holdings, Inc.
- Labeler DUNS
- 104162493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-11
- Public Version
- 1
- Public Version Date
- 2024-07-19
- Public Version Status
- New
- Public Device Record Key
- cae59b5c-db59-4253-8672-b7062dae207a
Device Description
Elbow extended, left
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
- No
- 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 |
|---|---|---|---|---|
| IXG | Phantom, Anthropomorphic, Radiographic | Radiology | 892.1950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40615 | General-purpose diagnostic x-ray phantom, anthropomorphic | A device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to mimic the functional, physical, or a combination of these characteristics of a normal or diseased human organ or organ systems. It is a quality assurance (QA) device intended to permit both subjective and quantitative evaluation of the overall function of both conventional and digital general-purpose x-ray systems and associated image acquisition, display and analysis computer programs. The design can incorporate fluid pumps and moveable components. This GMDN code includes biopsy and other kinds of interventional procedure training phantoms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812266030932 | GS1 |