FDA.reportPublic FDA data

Wood Applicator

Primary DI
00616784432328
Brand
Wood Applicator
Company
Dynarex Corporation
Model
4323
Device description
"Wood Applicator 6"""
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
KCJApplicator, Ent
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784432335PackageGS112In Commercial Distribution
00616784432328PrimaryGS10
00810180845175Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784432335006167844323356167844323350616784432335
00616784432328006167844323286167844323280616784432328
00810180845175008101808451758101808451750810180845175

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
008124539
Device count
864
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305571Resp-O2 (HEPA) Respiratory BV Filter304012021-04-22
00840117305595Resp-O2 Universal 6" Flex Tube, Connector: 15F/22F306002021-04-22
00840117305618Resp-O2 Tracheostomy Adult Flex Connector 15mmOD x 22mmOD/15mmID306012021-04-22
00840117305632Resp-O2 Tracheostomy Flex Connector, 15 mm OD x 15 mm ID306022021-04-22
00840117305670Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Adult/Pediatric310012021-04-22
00840117305694Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310022021-04-22
00840117305717Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310102021-04-22
00840117305731Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310112021-04-22
00840117305755Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310122021-04-22
00840117305861Resp-O2 Advantage Respiratory B/V Filter304002021-04-22
00840117319462Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310032021-04-22
00840117319486Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310132021-04-22
00840117319547Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Pediatric310002021-04-22
00840117344129Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Pediatric310042025-10-27
00840117344136Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Adult/Pediatric310052026-01-05
00840117344143Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Adult310062026-01-05
00840117344167Resp-O2 Vexta72 Closed Suction Tracheal Catheter310142026-01-05
00840117305311Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301042021-04-22
00840117305335Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301052021-04-22
00840117305359Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301062021-04-22

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Primary DI, Brand, Company table
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10889483563359BALLARD™SUNMED, LLCKXF2026-01-12
07613327680720Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
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10889483563274BALLARD™SUNMED, LLCKXF2025-11-17
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10889483563328BALLARD™SUNMED, LLCKXF2025-11-17
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10889483565520BALLARD™SUNMED, LLCKXF2025-11-17
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10889483565544BALLARD™SUNMED, LLCKXF2025-11-17
M220761002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
10840330701454ProCureTwin Med, LLCKXF2024-11-14
10840330701461ProCureTwin Med, LLCKXF2024-11-14
10840330701478ProCureTwin Med, LLCKXF2024-11-14
10840330701485ProCureTwin Med, LLCKXF2024-11-14
00616784430713"DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"""Dynarex CorporationKXF2024-11-11
00087701406973Good NeighborU.S. COTTON, LLCKXF2024-07-30
10817522013343SwabezeKENTEC MEDICAL, INC.KXF2024-06-20
16974488990782iCleanHuachenyang (Shenzhen) Technology Co., LtdKXF2023-12-01
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00618029830241SageSAGE PRODUCTS, LLCKXF2023-10-22
00618029850188SageSAGE PRODUCTS, LLCKXF2023-10-22
00618029830128Q-Care RxSAGE PRODUCTS, LLCKXF2023-09-07
00618029830210Q-Care RxSAGE PRODUCTS, LLCKXF2023-09-07