FDA.reportPublic FDA data

Lumohs

Primary DI
00850069257187
Brand
Lumohs
Company
NANO SURGICAL, INC
Model
1
Catalog number
RGB-1000-PRO-2
Device description
Lumohs Pro Kit - 2 Rechargable, illuminated wands, Dermaplane blade cartridge loader, 5-count #10R blades, USB Cable
Published
2026-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDZHandle, Scalpel
GESBlade, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850069257187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850069257187008500692571878500692571870850069257187

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure80 KiloPascal101 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-888-5866478help@lumohs.com

Regulatory Flags#

DUNS number
118747775
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850069257163Lumohs1RGB-1000-PRO2026-05-01
00850069257170Lumohs1RGB-1000-PRO-12026-05-01
00850069257002Lumohs1NLS-1900-102026-04-29
00850069257019Lumohs1NLS-1900-112026-04-29
00850069257026Lumohs1NLS-1900-152026-04-29
00850069257040Lumohs1NLS-1915-102026-04-29
00850069257057Lumohs1NLS-1915-10R2026-04-29
00850069257064Lumohs1NLS-1915-112026-04-29
00850069257071Lumohs1NLS-1915-152026-04-29
00850069257088Lumohs1NLS-1916-102026-04-29
00850069257095Lumohs1NLS-1916-10R2026-04-29
00850069257101Lumohs1NLS-1916-112026-04-29
00850069257118Lumohs1NLS-1916-152026-04-29
00850069257125Lumohs 1RGB-1015-10R2026-04-29
00850069257132Lumohs 1RGB-1015-102026-04-29
00850069257149Lumohs 1RGB-1015-112026-04-29
00850069257156Lumohs 1RGB-1015-152026-04-29
00850069257033Lumohs1NLS-1900-10R2026-02-20
10850069257030Lumohs1NLS-1900-10R2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811000040INKAThe Trustee for KAISER FAMILY TRUSTGDZ2025-11-19
10198459343513MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GES2025-05-22
08717903490228Humeca blade for Silver knifeHumeca B.V.GES2025-05-20
08717903490242Humeca blade for Humby long knife (20cm/7.9 in)Humeca B.V.GES2025-05-20
08717903490235Humeca blade for Humby, Cobbett and Watson knives (16 cm/6.3 in)Humeca B.V.GES2025-05-19
08902895180190KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
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08902895180213KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
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08902895182200KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182217KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182224KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182231KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
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