FDA.report

Wood Applicator

Primary DI
00616784432335
Brand
Wood Applicator
Company
DYNAREX CORPORATION
Model
4323
Device description
Wood Applicator 6"
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KCJApplicator, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784432335PackageGS112In Commercial Distribution
00616784432328PrimaryGS10
00616784432311Unit of UseGS10
00810180845175Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784432335006167844323356167844323350616784432335
00616784432328006167844323286167844323280616784432328
00616784432311006167844323116167844323110616784432311
00810180845175008101808451758101808451750810180845175

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
864
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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00810180844888Bed Pans42312021-04-22
00810180844895Nuns Cap Specimen Collector42322021-04-22
00840117331822DynaSafety Heavy Duty Woven Fabric Knuckle Bandages, 1 1/2" x 3"3765BULK2024-03-08
00840117331853DynaSafety Heavy Duty Woven Fabric Bandages, Large Patch, 2" x 3"3766BULK2024-03-08
00840117331907DynaSafety Heavy Duty Woven Fabric Bandages, Sterile, 7/8" x 3"3767BULK2024-03-08
00840117350045Pill Crusher Pouch42102021-09-01

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