FDA.report

Halyard

Primary DI
30680651299902
Brand
Halyard
Company
O&M HALYARD, INC.
Model
29990
Catalog number
29990
Device description
HALYARD* I.V. Therapy HAND-AID* Arterial Wrist Support, Pediatric
Published
2020-09-09
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
ILHSPLINT, HAND, AND COMPONENTS

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30680651299902PackageGS12In Commercial Distribution
20680651299905PrimaryGS10
90680651299904Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3068065129990230680651299902
2068065129990520680651299905
9068065129990490680651299904

GMDN Terms

TermDefinition
Wrist orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
081057389
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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