FDA UDI
In Commercial Distribution
🇺🇸 United States
Protech Proguard
DI: 08054301890213
·
Model: SleeveM
·
EMERSON & CO SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Protech Proguard
- Primary DI
- 08054301890213
- Version / Model
- SleeveM
- Catalog Number
- SleeveM
- Company Name
- EMERSON & CO SRL
- Labeler DUNS
- 630558211
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-15
- Public Version
- 1
- Public Version Date
- 2018-04-16
- Public Version Status
- New
- Public Device Record Key
- dc3b4c3e-13c7-4ebb-bbba-1d977559619e
Device Description
Radiation Reducing Sleeves
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPY | Shield, Protective, Personnel | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38369 | Radiation shielding material, ionizing | A radiation protection device that attenuates ionizing radiation used to create barriers between an individual or a specific body part and a source of primary or scattered radiation used in medical or dental procedures. This group of devices includes a variety of materials, e.g., lead (Pb) bricks and sheets, lead-equivalent materials, leaded glass or plastic, tungsten (W), low molecular weight plastics or hydrogenous materials. Examples of use can be: lead bricks to build protective structures, lead sheets used in walls and doors, leaded glass or leaded-plastic sheets used in windows, mouldable lead-equivalent plastic or thermoplastic materials used to shield specific anatomical areas. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08054301890954 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 08054301890213 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- in a dry place away from light and heat sources (below 35°).