FDA UDI
In Commercial Distribution
🇺🇸 United States
Child Panoramic Apron .25mm 24" X 27"
DI: 00812045039804
·
Model: 75062NL-34
·
Flow X Ray Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Child Panoramic Apron .25mm 24" X 27"
- Primary DI
- 00812045039804
- Version / Model
- 75062NL-34
- Company Name
- Flow X Ray Corporation
- Labeler DUNS
- 010016319
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-20
- Public Version
- 3
- Public Version Date
- 2023-06-28
- Public Version Status
- Update
- Public Device Record Key
- 516962bd-c06b-4f7e-890c-54e7caf03673
Device Description
Child Panoramic No Lead Apron .25mm 24" X 27" Paw Print
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
- Yes
- 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 |
|---|---|---|---|---|
| IWO | Apron, Protective | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64135 | Patient radiation shielding pad/drape, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812045039804 | GS1 |