FDA.report

Pill Crusher

Primary DI
00616784421131
Brand
Pill Crusher
Company
DYNAREX CORPORATION
Model
4211
Device description
Pill Crusher
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OHYPill Crusher/Cutter

Product Code Classifications

CodeDeviceSpecialtyClass
OHYPill Crusher/CutterGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784421131PackageGS16In Commercial Distribution
00616784421124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784421131006167844211316167844211310616784421131
00616784421124006167844211246167844211240616784421124

GMDN Terms

TermDefinition
Pill crusher/splitterA hand-held device designed for crushing or splitting in two medication in the form of a tablet for easier ingestion by a patient who cannot swallow the tablet whole. It is designed for convenience to be carried in the user's pocket or handbag (purse) and typically consists of several pieces that can be easily assembled by the user to crush or split the pill (tablet) by screwing the two main body parts against each other. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

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