FDA UDI
In Commercial Distribution
🇺🇸 United States
IMAGE DIAGNOSTICS, INC
DI: 00850061871152
·
Model: Protego FCM System for Philips Tables
·
IMAGE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IMAGE DIAGNOSTICS, INC
- Primary DI
- 00850061871152
- Version / Model
- Protego FCM System for Philips Tables
- Catalog Number
- A800-0250-PH01
- Company Name
- IMAGE DIAGNOSTICS, INC.
- Labeler DUNS
- 608235214
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-07
- Public Version
- 2
- Public Version Date
- 2025-12-15
- Public Version Status
- Update
- Public Device Record Key
- 5d823160-b8d9-4f03-8292-c447c3feab59
Device Description
IDI,RADIATION SHIELD SYSTEM,PROTEGO,FIXED CEILING MOUNT,METRIC ACCESSORY RAILS,PHILIPS,23" - 28" WIDTH TABLE TOP,WITH MOBILE BARRIER#A800-0250-PH01
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 |
|---|---|---|---|---|
| IWX | Barrier, Control Panel, X-Ray, Movable | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38375 | Radiation shielding curtain | A flexible radiation protective device intended to shield the operator or other attending persons from unnecessary exposure to radiation emitted during a medical or dental procedure. The curtain is a flexible radiation blocking or attenuating barrier located between the individual and the source of primary or scattered radiation. This radiation barrier is designed to hang from rods or tracks attached to the ceiling, wall, radiation delivery equipment, or other radiation shields. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of flexible lead (Pb) or lead-equivalent material. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850061871152 | GS1 |
Customer Contacts
- Phone
- 978-829-0009
- [email protected]