FDA UDI
In Commercial Distribution
🇺🇸 United States
SecureShield© EP 12" x 17" Scatter Reducing Drape
DI: 10860004894657
·
Model: SS-5400
·
Barrier Technologies, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SecureShield© EP 12" x 17" Scatter Reducing Drape
- Primary DI
- 10860004894657
- Version / Model
- SS-5400
- Company Name
- Barrier Technologies, LLC
- Labeler DUNS
- 621134084
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-29
- Public Version
- 1
- Public Version Date
- 2022-09-06
- Public Version Status
- New
- Public Device Record Key
- 16480248-d2b9-449d-89a4-449a43a094ea
Device Description
Excellent protection for device implant procedures such as Bi-V pacing, etc. Specially designed scoop fenestration allows easy access to site and maximum radiation protection. Specifically designed to protect the physician’s hand, body and head. The unique half-moon fenestration is large enough to allow easy access at the entry point, but small enough to block dangerous scatter radiation.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 64134 | Patient radiation shielding pad/drape, single-use | A protective device intended to be placed on/draped over part of a patient’s body during a diagnostic or therapeutic radiological procedure to shield specific patient anatomies from unnecessary exposure to radiation and/or help block scatter radiation from the patient to protect healthcare workers. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material; it is not a piece of clothing such as an apron. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10860004894657 | GS1 |