FDA UDI
In Commercial Distribution
🇺🇸 United States
SOOTHE-GUARD®
DI: D0036618050001
·
Model: 661805000
·
Dentsply International Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SOOTHE-GUARD®
- Primary DI
- D0036618050001
- Version / Model
- 661805000
- Catalog Number
- 661805000
- Company Name
- Dentsply International Inc.
- Labeler DUNS
- 795572718
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-24
- Public Version
- 1
- Public Version Date
- 2022-12-02
- Public Version Status
- New
- Public Device Record Key
- fad913f1-7f8a-4f3e-86c0-8d7640b6db8e
Device Description
Soothe-Guard® Adult Apron with Collar .35mm- Navy Blue
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EAJ | Apron, leaded | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38355 | Radiation shielding apron | A full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D0036618050001 | HIBCC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Models with magnetic closure may have potential magnetic interference with pacemakers, defibrillators, and other active implanted devices.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Hang or store flat