FDA UDI
In Commercial Distribution
🇺🇸 United States
Lumohs
DI: 00850069257033
·
Model: 1
·
NANO SURGICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lumohs
- Primary DI
- 00850069257033
- Version / Model
- 1
- Catalog Number
- NLS-1900-10R
- Company Name
- NANO SURGICAL, INC
- Labeler DUNS
- 118747775
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-20
- Public Version
- 1
- Public Version Date
- 2026-03-02
- Public Version Status
- New
- Public Device Record Key
- b8f7c187-92e8-48fc-826c-2a0cfcd471ed
Device Description
Illuminated Single-Use Scalpel, #10R Blade – White LED
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDX | Scalpel, One-Piece | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47569 | Scalpel, single-use | A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850069257030 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00850069257033 | GS1 |
Customer Contacts
- Phone
- 1-888-5866478
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10R Blade |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 80 – 101 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius