FDA.reportPublic FDA data

Lumohs

Primary DI
00850069257101
Brand
Lumohs
Company
NANO SURGICAL, INC
Model
1
Catalog number
NLS-1916-11
Device description
Illuminated Single-Use Scalpel, #11 Blade – Blue LED
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDXScalpel, One-Piece

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850069257108PackageGS110In Commercial Distribution
00850069257101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006925710810850069257108
00850069257101008500692571018500692571010850069257101

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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
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
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
00810111227346Scalpel Treace Medical Concepts, Inc.GDX2026-05-19
00850069257002LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257019LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257026LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257040LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257057LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257064LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257071LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257088LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257095LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257118LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257033LumohsNANO SURGICAL, INCGDX2026-02-20
16945630141826STERiLANCESterilance Medical (Suzhou) Inc.GDX2026-02-05
00818788021892Epimed International, Inc.EPIMED INTERNATIONAL, INCGDX2025-11-21
16945630137584index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137591index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137607index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137614index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139069index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139076index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
10198459343490MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GDX2025-05-22
16945630114080BardSterilance Medical (Suzhou) Inc.GDX2025-02-28
10197344025190MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025206MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025213MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
08902895129212KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129229KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129236KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129243KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129281KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09