FDA UDI
In Commercial Distribution
🇺🇸 United States
Laser Mixture
DI: 00860009625907
·
Model: 1
·
Red Ball Oxygen Co., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Laser Mixture
- Primary DI
- 00860009625907
- Version / Model
- 1
- Company Name
- Red Ball Oxygen Co., Inc.
- Labeler DUNS
- 049213267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 831999fc-8778-45c2-96a1-f34ccbe2a7da
Device Description
Gas, Laser Generating - Laser Mixture
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NXF | Gas, Laser Generating | General, Plastic Surgery | 878.4810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40931 | Laser-generating gas | A gaseous mixture intended to be used as a lasing medium (to produce a laser beam) typically for use in dermatological or general and plastic surgery procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009625907 | GS1 |