FDA UDI
In Commercial Distribution
🇺🇸 United States
Fluoro-Shield
DI: 00857164008034
·
Model: 011733M
·
MUNDY MEDICAL MARKETING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fluoro-Shield
- Primary DI
- 00857164008034
- Version / Model
- 011733M
- Catalog Number
- 0117333M
- Company Name
- MUNDY MEDICAL MARKETING INC
- Labeler DUNS
- 097037857
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-12
- Public Version
- 1
- Public Version Date
- 2018-07-13
- Public Version Status
- New
- Public Device Record Key
- b87c44b4-cd7d-4fae-adb2-bc3105fd11d5
Device Description
Radiation Reduction Gloves, Size 8 1/2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LZC | Patient Examination Glove, Specialty | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38364 | Radiation shielding glove | A personal protective device used to shield the entire hand or hands of an individual (i.e., the operator or other attending person) from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. Each finger is shielded individually. When used in diagnostic x-ray and nuclear medicine, it typically consists of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material. The glove offers radiation protection from all directions to the fingers, top and bottom of the hand. Some provide an additional physical barrier protection from liquid radioactive materials and body fluids. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857164008034 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K893093 | 000 |