FDA UDI
In Commercial Distribution
🇺🇸 United States
Pioneer Laser Laser Protective Glasses
DI: 00872320002459
·
Model: 002-00275
·
CAO GROUP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pioneer Laser Laser Protective Glasses
- Primary DI
- 00872320002459
- Version / Model
- 002-00275
- Catalog Number
- 002-00275
- Company Name
- CAO GROUP, INC.
- Labeler DUNS
- 102422578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-10
- Public Version
- 3
- Public Version Date
- 2019-05-23
- Public Version Status
- Update
- Public Device Record Key
- 54ca0a17-91b1-400b-ad15-940fe4fbe62a
Device Description
Laser protective eyewear for use with the Pioneer family of diode lasers.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38884 | Radiation shielding goggles/spectacles | A personal protective device in the form of eyewear/glasses with clear lenses intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. It is designed as uncorrected (non-prescription) or corrected (prescription) goggles or spectacles with lenses and side shields made of radiation-protecting materials (e.g., glass, plastic). The lenses and side shields offer additional physical barrier protection from liquid radioactive materials. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00872320002459 | GS1 |
Customer Contacts
- Phone
- 877-236-4402
- [email protected]