FDA.report

Cotton Tipped Wood Applicators, Non-Sterile

Primary DI
00616784430102
Brand
Cotton Tipped Wood Applicators, Non-Sterile
Company
DYNAREX CORPORATION
Model
4301
Device description
Cotton Tipped Wood Applicators, Non-Sterile, 3", 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
00616784430126PackageGS110In Commercial Distribution
00616784430133PackageGS110In Commercial Distribution
00616784430119PrimaryGS10
00616784430102Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784430126006167844301266167844301260616784430126
00616784430133006167844301336167844301330616784430133
00616784430119006167844301196167844301190616784430119
00616784430102006167844301026167844301020616784430102

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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