FDA.report

Halyard

Primary DI
30680651473395
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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LZCPatient examination glove, specialty

Product Code Classifications

CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30680651473395PackageGS110In Commercial Distribution
20680651473398PrimaryGS10
90680651473397Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3068065147339530680651473395
2068065147339820680651473398
9068065147339790680651473397

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags

DUNS number
081057389
Device count
250
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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