Identity
- Trade Name
- MasterPeace FDA UDI
- Generic Name
- Patient radiation shielding pad/drape, reusable FDA UDI
- Device Name
- Versatile Patient Shield L-shape. Versatile patient shield to be placed, e.g., over femoralis. Compatible with sterile pouch accessory (not included). FDA UDI
- Model / Reference
- Versatile Patient Shield FDA UDI
- Description
- Versatile Patient Shield L-shape. Versatile patient shield to be placed, e.g., over femoralis. Compatible with sterile pouch accessory (not included). FDA UDI
Identifiers
- Catalog Number
- PS3450 FDA UDI
- Primary DI / UDI-DI
- 07350121950528 FDA UDI
- FDA Product Code
- KPY FDA UDI
- GMDN Term
- Patient radiation shielding pad/drape, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 60 Centimeter FDA UDILength — 60 Centimeter FDA UDI
Category: Patient radiation shielding pad/drape, reusable
MasterPeace by Texray AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient radiation shielding pad/drape, reusable.
- ADULT BIB APRON with COLLAR ..25mm, No Lead, Royal Blue — Flow X-Ray Corp. · Class I
- ADULT BIB APRON with COLLAR ..25mm, No Lead, Red — Flow X-Ray Corp. · Class I
- Thyroid Collar .3mm 5" X 27" — Flow X-Ray Corp. · Class I
- APRON BIB .3MM 24X26/TYE DYE — Flow X-Ray Corp. · Class I
- Pro-Tek-To Pad — Flow X-Ray Corp. · Class I
- Adult Panoramic Apron .25mm 24" X 27" — Flow X-Ray Corp. · Class I
- Thyroid Collar .3mm 5" X 27" — Flow X-Ray Corp. · Class I
- Child Panoramic Apron .25mm 24" X 27" — Flow X-Ray Corp. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Texray AB
Sources (1)
- FDA UDI 5ede6b01-207c-47c1-a01d-7fa311c716c3 35 fields · synced May 30, 2026