FDA.reportPublic FDA data

Lumohs

Primary DI
00850069257170
Brand
Lumohs
Company
NANO SURGICAL, INC
Model
1
Catalog number
RGB-1000-PRO-1
Device description
Lumohs Pro Kit - 1 Rechargable, illuminated wand, 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
10850069257177PackageGS11In Commercial Distribution
00850069257170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006925717710850069257177
00850069257170008500692571708500692571700850069257170

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
00850069257187Lumohs1RGB-1000-PRO-22026-05-01
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
00810055255184Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255191Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255207Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255214Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255238Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255245Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255252Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255269Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255276Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255283Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255290Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255313Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255320Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255337Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255368Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255382Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255429Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255436Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255443Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255450Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255467Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255474Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255511Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255528Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255535Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255542Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255559Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255566Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255580Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255597Surgical DesignSurgical Design, Inc.GES2026-09-26