FDA.reportPublic FDA data

Medisca Safe-Sense

Primary DI
00338779574317
Brand
Medisca Safe-Sense
Company
Medisca Inc.
Model
5743-01
Catalog number
5743-01
Device description
"Gloves, Blue Nitrile Powder-Free, (M - 9""- 4 mil) (Non-Sterile) Medisca Safe-Sense"
Published
2023-05-15
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
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00338779574317PrimaryGS10
10338779574314Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00338779574317003387795743173387795743170338779574317
1033877957431410338779574314

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
794301960
Device count
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00338779597415Medisca Safe-Sense5974-015974-012023-05-12
00338779597514Medisca Safe-Sense5975-015975-012023-05-12
00338779597613Medisca Safe-Sense5976-015976-012023-05-12
00038779578314Medisca Safe-Sense5783-015783-012023-02-23
00338779597316Medisca Safe-Sense 5973-015973-012023-05-12
00338779553114MEDISCA TRANSFER PIPETTE5531-015531-012023-09-18
00338779998410Vaginal Suppository Applicator9984-019984-012023-09-10
00338779998427Vaginal Suppository Applicator9984-029984-022023-09-10
00338779998434Vaginal Suppository Applicator9984-039984-032023-09-10
10338779998417Vaginal Suppository Applicator9984-019984-012023-09-10
10338779998424Vaginal Suppository Applicator9984-029984-022023-09-10
10338779998431Vaginal Suppository Applicator9984-039984-032023-09-10
00038779733515PreciseDose Dispenser7335-017335-012023-03-15
00038779733522PreciseDose Dispenser7335-027335-022023-03-15
00338779559314MD Ophthalmic Dropper Bottles5593-015593-012023-05-15
00338779559321MD Ophthalmic Dropper Bottles5593-025593-022023-05-15
00338779565216Syringe with Tip Cap (For Oral/Topical Use)5652-015652-012023-05-15
00338779565223Syringe with Tip Cap (For Oral/Topical Use)5652-025652-022023-05-15
00338779565315Syringe with Tip Cap (For Oral/Topical Use)5653-015653-012023-05-15
00338779565322Syringe with Tip Cap (For Oral/Topical Use)5653-025653-022023-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975065506Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065513Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065520Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065537Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
00860010400937LuvatekR&C Imports LLCLZA2026-07-29
10304040195038CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.LZC2026-07-29
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00850084857379MedClickMedClick LLCLZA2026-07-22
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00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17