FDA.reportPublic FDA data

Halyard

Primary DI
20680651473398
Brand
Halyard
Company
O&M HALYARD, INC.
Model
47339
Catalog number
47339
Device description
STERLING SG* Nitrile Exam Glove ECO PULL*, XS
Published
2020-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZCPatient examination glove, specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651473395PackageGS110In Commercial Distribution
20680651473398PrimaryGS10
90680651473397Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065147339530680651473395
2068065147339820680651473398
9068065147339790680651473397

GMDN Terms#

Term, Definition table
TermDefinition
Leishmania donovani nucleic acid IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from the parasitic protozoan Leishmania donovani in a clinical specimen.

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags#

DUNS number
081057389
Device count
250
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20680651509646Halyard50964509642026-05-14
20680651509653Halyard50965509652026-05-14
20680651509660Halyard50966509662026-05-14
20680651509677Halyard50967509672026-05-14
20680651509684Halyard50968509682026-05-14
20680651484219Halyard48421484212022-05-06
20680651484226Halyard48422484222022-05-06
10680651385250Halyard38525385252023-07-31
20680651372219Halyard37221372212020-11-16
20680651372509Halyard37250372502020-11-16
20680651718000Halyard71800718002020-08-31
20680651718253Halyard71825718252020-11-16
20680651719007Halyard71900719002020-11-16
30680651494390Halyard49439494392025-03-26
30680651494406Halyard49440494402025-03-26
30680651494413Halyard49441494412025-03-26
30680651494420Halyard49442494422025-03-26
30680651494437Halyard49443494432025-03-26
20680651395072Halyard39507395072020-09-15
20680651395089Halyard39508395082020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557407Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557438Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557469Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557490Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12