Identity
- Trade Name
- GRID Facile FDA UDI
- Generic Name
- Stationary x-ray grid FDA UDI
- Device Name
- 478x1288mm, 8:1,103, Parallel with Frame type FDA UDI
- Model / Reference
- GTSHS10100034S0001 FDA UDI
- Description
- 478x1288mm, 8:1,103, Parallel with Frame type FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04589744212581 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary x-ray grid
GRID Facile by Mitaya Manufacturing Co., Ltd. — 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
- Box for radiographic Grid-1000(P-15 (outside 1440mmx890mmx590mm)) — Jpi Healthcare, Inc. · Class I
- Anti-scatter Grid (60/10/180) — Philips Medical Systems GmbH, Dmc · Class I
- Anti-scatter Grid (36/12/100) — Philips Medical Systems GmbH, Dmc · Class I
- Box for radiographic Grid-1000(for SSME(outside 569mmx539mm & thickness 38mm)) — Jpi Healthcare, Inc. · Class I
- Box for radiographic Grid-1000(P-5(outside 1440mmx190mmx160mm)) — Jpi Healthcare, Inc. · Class I
- Grid Portrait for SkyPlate large — Philips Medical Systems GmbH, Dmc · Class I
- Box for radiographic Grid-1000(15"x18"(outside 523mmx481mm) — Jpi Healthcare, Inc. · Class I
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
- Mitaya Manufacturing Co., Ltd.
Sources (1)
- FDA UDI fca7acda-210d-4b7e-b934-f2c9ca674048 33 fields · synced May 30, 2026