FDA UDI
In Commercial Distribution
🇺🇸 United States
SecureShield© Multipurpose with fenestration 12" x 17" Scatter Reducing Drape
DI: 10860004894633
·
Model: SS-5200
·
Barrier Technologies, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SecureShield© Multipurpose with fenestration 12" x 17" Scatter Reducing Drape
- Primary DI
- 10860004894633
- Version / Model
- SS-5200
- 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
- e6490dcf-6188-416f-a474-a14f226d26a4
Device Description
Outstanding protection during all types of biopsy procedures. Rectangular fenestration allows access and viewing while minimizing radiation exposure. The SecureShield Biopsy Shield provides excellent protection during any needle biopsy or puncture procedure. This versatile shield can be effectively used at any location on the body.
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 | 10860004894633 | GS1 |