FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Paneffort
DI: 10810101310482
·
Model: ACF-FMHB-9RU
·
Paneffort, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Paneffort
- Primary DI
- 10810101310482
- Version / Model
- ACF-FMHB-9RU
- Company Name
- Paneffort, LLC
- Labeler DUNS
- 018250858
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-06-03
- Public Version
- 2
- Public Version Date
- 2024-09-30
- Public Version Status
- Update
- Public Device Record Key
- 14bd23fa-6323-4435-8903-7e17ed859ca2
- Distribution End Date
- 2023-01-01
Device Description
Disposable Anti-Fog Face Shield. Full Length, Foam Head Protection, Elastic Head Band. Regular/Large
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
- 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
- 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 |
|---|---|---|---|---|
| KPY | Shield, Protective, Personnel | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11961 | Face splash shield, single-use | A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810101310482 | GS1 | ||||
| Unit of Use | 00810101310485 | GS1 |