FDA.reportPublic FDA data

MolecuLight DarkDrape

Primary DI
00628110259295
Brand
MolecuLight DarkDrape
Company
MolecuLight Inc
Model
1426
Device description
Drapes that are individually packaged for one-time use to create an optimal lighting environment for imaging wounds while using the MolecuLight i:X.
Published
2022-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628110259301PackageGS150In Commercial Distribution
00628110259295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628110259301006281102593016281102593010628110259301
00628110259295006281102592956281102592950628110259295

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Regulatory Flags#

DUNS number
202822052
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628110259639MolecuLightDX®+ Essential System31552026-09-29
00628110259530MolecuLightDX®+ Enterprise System26352026-07-08
00628110259448MolecuLightDX Sterile Surgical Sleeve Convenience Kit of 2520962026-07-08
00628110259547Thermal Imaging Module26402026-07-08
00628110259554MolecuLightDX Eco DarkDrapes (Case of 50)25172026-07-08
00628110259578MolecuLightDX DarkDrape Eco Clip23932026-07-08
00628110259585MolecuLightDX+ Thermal Eco Clip23952026-07-08
00628110259363i:X Sterile Surgical Sleeve Convenience Kit18592022-01-05
00628110259394MolecuLightDX DarkDrape19732022-01-05
00628110259325MolecuLight i:X System1153-112022-01-04
00628110259387MolecuLightDX System20942022-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08684382977444SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382977451SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382999712SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
00850067913238SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913245SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913252SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913269SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913276SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913283SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913085SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913092SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913108SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913115SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913122SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913139SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913146SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913153SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913160SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913191SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913214SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913221SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00748426264575Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
10192253072211CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072228CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072235CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072242CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072259CONVERTORSCardinal Health 200, LLCPUI2026-10-14
20193489029946MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20748426264531Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20748426264593Medline-MicrotekMicrotek Medical LLCPUI2026-10-14