Identity
- Trade Name
- ABSORBER SHIELD FDA UDI
- Generic Name
- Radiation shielding blanket FDA UDI
- Device Name
- The absorber shields are discs used to radioprotect the patient’s organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision. FDA UDI
- Model / Reference
- Diameter 90 mm FDA UDI
- Description
- The absorber shields are discs used to radioprotect the patient’s organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision. FDA UDI
Identifiers
- Catalog Number
- N394090-02-05 FDA UDI
- Primary DI / UDI-DI
- 08057014730463 FDA UDI
- 510(k) Number
- K112286 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiation shielding blanket FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Circumference — 90 Millimeter FDA UDI
Category: Radiation shielding blanket
Absorber Shield by Sit Sordina Iort Technologies Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation shielding blanket.
- RADPAD — Worldwide Innovations & Technologies, Inc. · Class I
- RADPAD — Worldwide Innovations & Technologies, Inc. · Class I
- RADPAD — Worldwide Innovations & Technologies, Inc. · Class I
- RADPAD — Worldwide Innovations & Technologies, Inc. · Class I
- RADPAD — Worldwide Innovations & Technologies, Inc. · Class I
- RADPAD — Worldwide Innovations & Technologies, Inc. · Class I
- RADPAD — Worldwide Innovations & Technologies, Inc. · Class I
- RADPAD — Worldwide Innovations & Technologies, Inc. · Class I
Cleared under the same submission
K112286 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sit Sordina Iort Technologies Spa
Sources (1)
- FDA UDI 509041ed-f7cb-43d8-8380-752c23293106 38 fields · synced May 30, 2026