Identity
- Trade Name
- DRX Plus 4343 DETECTOR FDA UDI
- Generic Name
- Stationary x-ray grid FDA UDI
- Device Name
- DRX Plus 4343 portable grid holder FDA UDI
- Model / Reference
- DRX Plus 4343 DETECTOR FDA UDI
- Description
- DRX Plus 4343 portable grid holder FDA UDI
Identifiers
- Catalog Number
- 1746148 FDA UDI
- Primary DI / UDI-DI
- 60889971746146 FDA UDI
- 510(k) Number
- K090318 FDA UDI
- FDA Product Code
- IXJ FDA UDI
- GMDN Term
- Stationary x-ray grid FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Stationary x-ray grid
DRX Plus 4343 DETECTOR by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary x-ray grid.
- Box for radiographic Grid-1000(18"x18"(outside 525mmx560mm)) — Jpi Healthcare, Inc. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- Box for radiographic Grid-1000(P-15 (outside 1440mmx890mmx590mm)) — Jpi Healthcare, Inc. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
- MS X-RAY GRID — Mitaya Manufacturing Co., Ltd. · Class I
Cleared under the same submission
K090318 also covers:
- CARESTREAM DRX-1 System — CARESTREAM HEALTH, INC.
- CARESTREAM DRX-1 System — CARESTREAM HEALTH, INC.
- CARESTREAM DRX-1 System — CARESTREAM HEALTH, INC.
- CARESTREAM DRX-1 System — CARESTREAM HEALTH, INC.
- CARESTREAM DRX-1 System Detector — CARESTREAM HEALTH, INC.
- DRX-1 Detector — CARESTREAM HEALTH, INC.
- DRX-Transportable System — CARESTREAM HEALTH, INC.
- DRX-Transportable System — CARESTREAM HEALTH, INC.
- DRX-Transportable System — CARESTREAM HEALTH, INC.
- DRX-Transportable System — CARESTREAM HEALTH, INC.
- TDR 3543 Detector — CARESTREAM HEALTH, INC.
- TDR 3543C Detector — CARESTREAM HEALTH, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Carestream Health, Inc.
Sources (1)
- FDA UDI 7d813f5c-5590-42d7-a4e6-a1541c2808af 35 fields · synced Jun 8, 2026