FDA.reportPublic FDA data

APPLICATOR

Primary DI
16973069980143
Brand
APPLICATOR
Company
Dalian Rongbang Medical Healthy Devices Co., Ltd.
Model
NA
Published
2022-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KCJApplicator, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCJApplicator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973069980143PrimaryGS10
26973069980140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697306998014316973069980143
2697306998014026973069980140

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
529882730
Device count
10
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973069980023Tongue Depressor16092023-10-04
16973069980020Tongue Depressor16092023-10-04
16973069980013DepressorsNA2022-09-07
16973069980051Disposable sampling swabNA2022-09-07
16973069980235SpoonNA2022-09-08
26973069980058 Disposable sampling swabNA2022-09-07
06973069980238SpoonNA2022-09-08
06973069980016DepressorsNA2022-09-07
06973069980054Disposable sampling swabNA2022-09-07
06973069980146APPLICATORNA2022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770410972Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420179Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770420766Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00757770427383Bausch + LombBausch & Lomb IncorporatedKCJ2025-07-29
00850027492698NavägeRhinosystems, Inc.KCJ2024-11-15
00887482037898Symmetry FarrellASPEN SURGICAL PRODUCTS, INC.KCJ2024-08-15
00840183517489BR Surgical, LLCBR Surgical, LLCKCJ2024-05-29
04055207009734NARichard Wolf GmbHKCJ2024-05-21
00850022483073Saline Noze MistDr. Noze Best, LLCKCJ2024-02-05
G586E1032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E1035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032250Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032270Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032290Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032750Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032770Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91032790Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035460Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
G586E91035960Novo SurgicalNOVO SURGICAL, INC.KCJ2023-12-18
00842331192524Novo Surgical Inc. NOVO SURGICAL, INC.KCJ2023-12-07
05060259070426Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070488Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070853DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070983DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259070990DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259073120DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
05060259073137DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259070420Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
45060259070486Sigma SwabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05
25060259070857DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCJ2023-10-05