FDA UDI
In Commercial Distribution
🇺🇸 United States
ABSORBER SHIELD
DI: 08057014730449
·
Model: Diameter 70 mm
·
S.I.T. SORDINA IORT TECHNOLOGIES SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ABSORBER SHIELD
- Primary DI
- 08057014730449
- Version / Model
- Diameter 70 mm
- Catalog Number
- N394070-02-05
- Company Name
- S.I.T. SORDINA IORT TECHNOLOGIES SPA
- Labeler DUNS
- 339852325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 62caf6a9-fcee-4082-b686-27dec0bbc043
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38357 | Radiation shielding blanket | A personal protective device intended to shield selected body parts of a patient, or others, from unnecessary exposure to radiation during diagnostic or therapeutic medical or dental procedures. Radiation protection blankets used in diagnostic x-ray and nuclear medicine typically consist of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material. Blankets intended to attenuate neutrons are composed of hydrogenous materials instead of lead. Blankets used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057014730449 | GS1 |
Customer Contacts
- Phone
- +390692062446
- [email protected]
- Phone
- +390692062446
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112286 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 70 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius