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
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01