FDA UDI
In Commercial Distribution
🇺🇸 United States
RC-115
DI: 00868162000289
·
Model: RC-115
·
SOURCE-RAY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RC-115
- Primary DI
- 00868162000289
- Version / Model
- RC-115
- Catalog Number
- 900035
- Company Name
- SOURCE-RAY, INC.
- Labeler DUNS
- 113928654
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 5
- Public Version Date
- 2022-09-23
- Public Version Status
- Update
- Public Device Record Key
- bba4458e-28dd-439d-be94-b57d6ddd8719
Device Description
X-Ray Control, Remote
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 |
|---|---|---|---|---|
| IZL | System, X-Ray, Mobile | Radiology | 892.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61587 | Diagnostic radiography device remote control | A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the position/movement of a digital diagnostic radiography device (e.g., flat-panel detector, radiology table) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00868162000289 | GS1 |
Customer Contacts
- Phone
- 631-244-8200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062472 | 000 |