FDA UDI
In Commercial Distribution
🇺🇸 United States
Clear-All Face Shield
DI: 00723896017678
·
Model: 701787
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
8
Basic Information
- Brand Name
- Clear-All Face Shield
- Primary DI
- 00723896017678
- Version / Model
- 701787
- Catalog Number
- 701787
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2020-11-16
- Public Version
- 1
- Public Version Date
- 2020-11-24
- Public Version Status
- New
- Public Device Record Key
- f07f0c02-e2ef-40dd-846e-bf17a4032a7f
Device Description
Finally, there is a face shield specifically designed to fit over loupes and headlamps. The Clear-All Face Shield is super lightweight and comfortable with ample forward clearance. Black hook-and-loop headband doubles as forehead pad. Entire shield can be washed and reused. Antifog PET construction. 12" long with extended wraparound protection. Eight complete shields per pack.
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | 878.4040 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00723896017661 | GS1 | ||||
| Primary | 00723896017678 | GS1 |