FDA.report

Cotton Tipped Wood Applicators, Non-Sterile

Primary DI
00616784430201
Brand
Cotton Tipped Wood Applicators, Non-Sterile
Company
DYNAREX CORPORATION
Model
4302
Device description
Cotton Tipped Wood Applicators, Non-Sterile, 6", 100 per Pouch
Published
2022-04-22
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

Product Codes

CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784430225PackageGS110In Commercial Distribution
00616784430232PackageGS110In Commercial Distribution
00616784430218PrimaryGS10
00616784430201Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784430225006167844302256167844302250616784430225
00616784430232006167844302326167844302320616784430232
00616784430218006167844302186167844302180616784430218
00616784430201006167844302016167844302010616784430201

GMDN Terms

TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
100
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
false
Sterilization required before use
false

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