FDA UDI
In Commercial Distribution
🇺🇸 United States
DRAPE ARMOUR™
DI: 00748426143443
·
Model: Drape Armour FPS
·
Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DRAPE ARMOUR™
- Primary DI
- 00748426143443
- Version / Model
- Drape Armour FPS
- Catalog Number
- RBFPS102
- Company Name
- Microtek Medical LLC
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-23
- Public Version
- 1
- Public Version Date
- 2025-10-01
- Public Version Status
- New
- Public Device Record Key
- c17373d9-033a-4f96-ad41-ad45666d16ba
Device Description
DRAPE ARMOUR™, L-Shape Radiation Protection Shield, 41 cm x 33 cm x 20 cm (16 in x 13 in x 8 in), Attenuation: 88.3% - 90.3% at 90 kVp
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPY | Shield, Protective, Personnel | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38375 | Radiation shielding curtain | A flexible radiation protective device intended to shield the operator or other attending persons from unnecessary exposure to radiation emitted during a medical or dental procedure. The curtain is a flexible radiation blocking or attenuating barrier located between the individual and the source of primary or scattered radiation. This radiation barrier is designed to hang from rods or tracks attached to the ceiling, wall, radiation delivery equipment, or other radiation shields. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of flexible lead (Pb) or lead-equivalent material. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10748426143440 | GS1 | case | 10 | In Commercial Distribution | |
| Primary | 00748426143443 | GS1 |