FDA UDI
In Commercial Distribution
🇺🇸 United States
NorLab
DI: 00860009621923
·
Model: Medical Laser Gas
·
Norco, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NorLab
- Primary DI
- 00860009621923
- Version / Model
- Medical Laser Gas
- Company Name
- Norco, Inc.
- Labeler DUNS
- 043694645
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-12
- Public Version
- 1
- Public Version Date
- 2022-12-20
- Public Version Status
- New
- Public Device Record Key
- 272d017f-85d4-44e4-b246-1f749ab4b33b
Device Description
Gases used as a medium for various medical lasers.
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
- No
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
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 | 00860009621923 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K904162 | 000 |