Gafchromic™
Blood Irradiation Indicator
3manufacturers in China registered for this device type
151catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Rayco (Xiamen) Medical Products Company Limited | Xiamen | Fujian | Contract manufacturer | 1 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
Record
| Listed by | Ashland Specialty Ingredients, G.P., United States |
|---|---|
| FDA product code | IWZ |
| Device type | Film, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1840 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-06 |
| Record revised | 2024-09-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-12-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MD-V3 Calibration Strip @50SH | In distribution | |
| HD-V2 IO 22685-2 @ 50SH | In distribution | |
| EBT3 20CM CIRCLE UP @25SH | In distribution | |
| MD-V3 8×10 @10SH | In distribution | |
| MD-V3 5X5 @5SH | In distribution | |
| EBT3 MAX-HD 2.0 @35SH | In distribution | |
| RTQA2 10x10P @25SH | In distribution | |
| EBT4 Phantom 8X10 @25SH | In distribution | |
| EBT4 40MM x 50MM @30SH | In distribution | |
| EBT4 65MM x 65MM @22SH | In distribution | |
| EBT4 Max-EA Film Insert 6 | In distribution | |
| RTQA2 13.8X17 (x10) | In distribution | |
| EBT3 LARS AX + SG @20SH | In distribution | |
| EBT3 150MM x 150MM @26SH | In distribution | |
| EBT3 DP-1000 @20SH | In distribution | |
| EBT-XD DP-850 @20SH | In distribution | |
| EBT XD Custom 7.5 X 6 @50SH | In distribution | |
| RTQA2 1.25X11 (x25) | In distribution | |
| EBT-4 CIRS STEEV @ 20SH | In distribution | |
| EBT-XD MAX-HD 2.0 @35SH | In distribution | |
| EBT4 Ballcube II w/o Slit @10PR | In distribution | |
| Lateral Correction Film Kit S | In distribution | |
| HD-V2 8×10 @10SH | In distribution | |
| MD-V3 1X1CM @250SH | In distribution | |
| EBT-4 35MM @ 100SH | In distribution | |
| EBT-XD AQA @100SH | In distribution | |
| 1.3X2 @300SH | In distribution | |
| MD-V3 1.3X2 @200SH | In distribution | |
| HD-V2 2X2.5 @50SH | In distribution | |
| EBT3 Baby Blue Phantom @30SH | In distribution | |
| EBT-XD Ballcube II @32SH | In distribution | |
| EBT4 10CMx10CM w/ 3 Holes @25PR | In distribution | |
| EBT3 Reflexion Film V2 @20SH | In distribution | |
| EBT4-XD Lucy-EA Multi @6 | In distribution | |
| EBT-XD 8X10 SAMPLE @3SH | In distribution | |
| EBT-XD 1X1CM @20SH | In distribution | |
| EBT3 5CM X 5CM @50SH | In distribution | |
| HD-V2 Calibration Strip @50SH | In distribution | |
| MD-V3 12.5CM X 29CM @25SH | In distribution | |
| EBT4 Disc Gyro @20 | In distribution | |
| EBT-XD Mini Ballcube @20SH | In distribution | |
| EBT4 1.3×2 @300SH | In distribution | |
| EBT3 AQA @100SH | In distribution | |
| EBT-XD MAX-EA Ortho Film 1 @8SH | In distribution | |
| EBT4 Max-EA Film Insert 3 | In distribution | |
| EBT-XD MAX-EI @20SH | In distribution | |
| LD-V1 8X10 SAMPLE @3SH | In distribution | |
| XR-CT3 0.75 X 5 @50SH | In distribution | |
| EBT4 14X17 @10SH | In distribution | |
| EBT-XD Baby Blue Phantom @30SH | In distribution | |
| EBT-XD STV-PHANTOM @32SH | In distribution | |
| Lateral Correction Film Kit L | In distribution | |
| EBT4 Lucy EA Ortho Set | In distribution | |
| RTQA2 10×10 (x25) | In distribution | |
| EBT-XD 2.756 IO @50SH | In distribution | |
| EBT-XD Lateral Film Block @30SH | In distribution | |
| EBT-XD MAX-EA Ortho Film 2 @8SH | In distribution | |
| EBT4 Reflexion Film V2 @20SH | In distribution | |
| EBT4 6CMx6CM w/ 3 Holes @100PR | In distribution | |
| EBT4 Lucy EA Sagittal Neck | In distribution | |
| EBT-XD Sagittal Film Set @19SH | In distribution | |
| RTQA2 10X10 SAMPLE @3SH | In distribution | |
| EBT4 5CMx5CM @50PR | In distribution | |
| EBT-4 18 MM @ 100SH | In distribution | |
| EBT3 Ballcube II w/o slit @32SH | In distribution | |
| MD-V3 12.5CM X 29CM @10SH | In distribution | |
| EBT3 14.95CM SQ W N @25SH | In distribution | |
| EBT4 Mini Ballcube @10PR | In distribution | |
| EBT-4 ZAP CAL STRIP @12SH | In distribution | |
| EBT3 Calibration Strip @50SH | In distribution | |
| EBT-XD MAX-EA Ortho Cal Strip @10SH | In distribution | |
| EBT3 Ballcube I @20SH | In distribution | |
| EBT4 AQA @100SH | In distribution | |
| EBT-XD CAL STRIP MX-HD @25SH | In distribution | |
| LD-V1 4 X 2.5 @20SH | In distribution | |
| EBT-XD Thorax Phantom Film @22SH | In distribution | |
| EBT-XD DP-1000 @20SH | In distribution | |
| LD-V1 75MM x 75MM @12SH | In distribution | |
| EBT3 MX-HD BLCK-2D ANT | In distribution | |
| EBT3 2 X 2.5 @50SH | In distribution | |
| HD-V2 1.3×2 @50SH | In distribution | |
| EBT3 IMT-003-26 @21SH | In distribution | |
| EBT-XD RBY @ 50SH | In distribution | |
| EBT-XD 8X10 @25SH | In distribution | |
| EBT4 Max-EA Film Insert 1 | In distribution | |
| EBT-XD Ballcube II w/o slit @32SH | In distribution | |
| EBT3 Reflexion Film @32SH | In distribution | |
| EBT4 Max-EA Ventricle Film | In distribution | |
| EBT3 MAX-EI @20SH | In distribution | |
| ThorX Rod Film @5 | In distribution | |
| EBT4 Max-EA Sagittal Film | In distribution | |
| EBT3 15X15CM @25 SH | In distribution | |
| EBT-XD Lucy Ortho @1 | In distribution | |
| EBT4 Lucy EA Multi Set | In distribution | |
| EBT4 Lucy-EA Cal Strip | In distribution | |
| LD-V1 1.5 X 1.5 @20SH | In distribution | |
| EBT4 XLT @10PR | In distribution | |
| EBT4 Max-EA Film Insert 5 | In distribution | |
| EBT4 Ballcube II @10PR | In distribution | |
| EBT3 DP-850 @20SH | In distribution | |
| EBT-XD Calibration Strip @50SH | In distribution | |
| EBT4 Ballcube I @10PR | In distribution | |
| EBT-XD 1X1CM @500 SH | In distribution | |
| XR-RV3 13.8X17 (x10) | In distribution | |
| EBT3 IMT CAL STRIP @25SH | In distribution | |
| MD-V3 2.5X2.5 @20SH | In distribution | |
| EBT3 Ballcube I w/o holes @20SH | In distribution | |
| EBT3 12.8X17 @10SH | In distribution | |
| LD-V1 8X10 @10SH | In distribution | |
| XR-M3 1 X 3 @50SH | In distribution | |
| EBT3 8X10 @ 25SH | In distribution | |
| EBT3 XLT @20SH | In distribution | |
| EBT3 Thorax Phantom Film @22SH | In distribution | |
| EBT3 Ballcube II @32SH | In distribution | |
| EBT4 Max-EA Film Insert 4 | In distribution | |
| EBT3 Sagittal Film Set @19SH | In distribution | |
| EBT3 Phantom 8X10 @25 SH | In distribution | |
| EBT4 Zap Film 1 → 00366 @10SH | In distribution | |
| EBT4 ELTRA-NH @50SH | In distribution | |
| EBT-4 ZAP CAL STRIP @12SH | In distribution | |
| EBT4 Calibration Strip | In distribution | |
| RTQA2 Calibration Strip @50SH | In distribution | |
| LD-V1 3×3 @20SH | In distribution | |
| EBT4 8X10 @25SH | In distribution | |
| LD-V1 10X12 @10SH | In distribution | |
| EBT3 3X3 @30SH | In distribution | |
| EBT3 Mini Ballcube @20SH | In distribution | |
| EBT3 Lateral Film Block @30SH | In distribution | |
| EBT4 Max-EA Film Insert 2 | In distribution | |
| MD-V3 1X1CM @500SH | In distribution | |
| ThorX Spine Film Insert @5 | In distribution | |
| EBT-XD IO 22685-1 @ 50SH | In distribution | |
| EBT-XD XLT @20SH | In distribution | |
| EBT3 3X3 @60SH | In distribution | |
| EBT-XD Ballcube I @20SH | In distribution | |
| EBT3 8X10 SAMPLE @3SH | In distribution | |
| XR-RV3 Comparator Strip | In distribution | |
| EBT4 Zap Film 2 → 003667 @10SH | In distribution | |
| EBT-XD MX-HD BLCK-2D ANT @50SH | In distribution | |
| EBT4 8X10 SAMPLE @3SH | In distribution | |
| XR-CT2 0.75×5 @50 SH | Withdrawn | |
| XRQA2 Calibration Strip @50SH | Withdrawn | |
| XRSP2 4×2.5 @20SH | Withdrawn | |
| XR-QA2 10×12 (x10) | Withdrawn | |
| XR-QA2 4×2.5 (x20) | Withdrawn | |
| XR-QA2 1.5×1.5 (x20) | Withdrawn | |
| EBT4 Lucy-EA Multi @6 | Withdrawn | |
| XR-SP2 8×10 | Withdrawn | |
| XR-QA2 8×10 (x10) | Withdrawn | |
| XR-SP2 10×12 | Withdrawn | |
| XR-M2 1X3 @50SH | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dryview DVB Laser Imaging Film | Carestream Health, Inc. | 42 |
| Imaging Plates | Palodex Group OY | 24 |
| Henry Schein | Henry Schein, Inc. | 24 |
| Fuji Medical X-RAY Film | Fujifilm Corporation | 21 |
| Ultra-speed | Carestream Health, Inc. | 17 |
| T-MAT G/RA Film | Carestream Health, Inc. | 16 |
| Dryview DVM Mammography Laser Imaging Film | Carestream Health, Inc. | 16 |
| E Blue X-ray Film WB | Carestream Health, Inc. | 15 |
| Medical X-ray Green / MXG Film | Carestream Health, Inc. | 15 |
| Rad Control | Typenex Medical, LLC | 15 |
| Insight | Carestream Health, Inc. | 15 |
| Medical X-ray Blue / MXB Film | Carestream Health, Inc. | 15 |
Showing 12 of 259. All products under Film, Radiographic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.