FDA.reportPublic FDA data

DERMATOUCH

Primary DI
00810169801864
Brand
DERMATOUCH
Company
PRIME SOLUTIONS, INC.
Model
81140MD/M
Published
2025-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810169801932PackageGS110In Commercial Distribution
00810169801864PrimaryGS10
10810169801861Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810169801932008101698019328101698019320810169801932
00810169801864008101698018648101698018640810169801864
1081016980186110810169801861

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor XI inhibitor IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of coagulation factor XI inhibitor in a clinical specimen.

Regulatory Flags#

DUNS number
093300590
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810169802373DERMATOUCH82235MD/XS2026-04-24
00810169802380DERMATOUCH82235MD/S2026-04-24
00810169802397DERMATOUCH82235MD/M2026-04-24
00810169802403DERMATOUCH82235MD/L2026-04-24
00810169802410DERMATOUCH82235MD/XL2026-04-24
00810169802427DERMATOUCH82235MD/XXL2026-04-24
00810169802199DERMATOUCH81260MD/S2026-02-10
00810169802205DERMATOUCH81260MD/M2026-02-10
00810169802212DERMATOUCH81260MD/L2026-02-10
00810169802229DERMATOUCH81260MD/XL2026-02-10
00810169802236DERMATOUCH81260MD/2XL2026-02-10
00810169802243DERMATOUCH81260MD/S2026-02-10
00810169802250DERMATOUCH81260MD/M2026-02-10
00810169802267DERMATOUCH81260MD/L2026-02-10
00810169802274DERMATOUCH81260MD/XL2026-02-10
00810169802281DERMATOUCH81260MD/2XL2026-02-10
00810169800911DERMATOUCH81150MD/S2025-12-30
00810169800928DERMATOUCH81150MD/M2025-12-30
00810169800935DERMATOUCH81150MD/L2025-12-30
00810169800942DERMATOUCH81150MD/XL2025-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100PNK1MYNTMynt ProfessionalLZA2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15