FDA.report

Rhinostics, Inc.

Primary DI
00850042963142
Brand
Rhinostics, Inc.
Company
Rhinostics Inc
Model
HS-S000001
Device description
HIPPOstic TM
Published
2023-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850042963159PackageGS12016In Commercial Distribution
00850042963166PackageGS12000In Commercial Distribution
00850042963265PackageGS196In Commercial Distribution
00850042963272PackageGS196In Commercial Distribution
00850042963142PrimaryGS10

GMDN Terms

TermDefinition
Oral/upper respiratory tract specimen collection swabA piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for culture, analysis, and/or other investigation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
100216104
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850042963326Rhinostics, Inc.LVL-10000052024-05-24
00850042963012Rhinostics, Inc.LVL-10000012023-09-18
00850042963074Rhinostics, Inc.LVL-10000022023-09-18
00850042963098Rhinostics, Inc.LVL-10000032023-09-18
00850042963128Rhinostics, Inc.VS-S0000012023-03-28
00850042963005Rhinostics, Inc.PG-1000012023-03-27
00850042963043Rhinostics, Inc.RH-S0001112023-03-27
00850042963081Rhinostics, Inc.LV-2D1D0032023-03-27
00850042963104Rhinostics, Inc.LV-2D1D0022023-03-27
00850042963111Rhinostics, Inc.GW-UF1000012023-03-24

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M220767003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
M220768003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
M220768013Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
00840456214916JMUJMU DENTAL, INCKXG2025-07-15
00840456214923JMUJMU DENTAL, INCKXG2025-07-15
58053326011653CLASSIQSwabCOPAN ITALIA SPAKXG2025-07-03
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00842558116402BactiSwab Dry PK/100REMEL, INC.KXG2025-06-19
00810180840958LabChoice Transport Swabs, Wooden Shaft, Cotton Tip, Sterile Dynarex CorporationKXG2025-02-28
00810180840965LabChoice Transport Swabs, Wooden Shaft, Viscose Tip, SterileDynarex CorporationKXG2025-02-28
00810180840972LabChoice Transport Swabs, Snappable Polystyrene Shaft, Cotton Tip, Sterile Dynarex CorporationKXG2025-02-28
00840117329706LabChoice Transport Swabs, Snappable Polystyrene Shaft, Viscose Tip, SterileDynarex CorporationKXG2025-02-28
00840165400372Starswab Dry SwabPretium Canada Packaging ULCKXG2025-02-21
00840165400396Starswab Dry SwabPretium Canada Packaging ULCKXG2025-02-21
05060166524524Oracol MALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
05060166525743Oracol SwabMALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
05060166524531Oracol+MALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
58053326011684FLOQSwabs® COPAN ITALIA SPAKXG2024-12-18
00603266511848Super BrushSuper Brush, LLCKXG2024-08-30
10603266530839Super BrushSuper Brush, LLCKXG2024-08-30
10603266531874Super BrushSuper Brush, LLCKXG2024-08-30
10603266533830Super BrushSuper Brush, LLCKXG2024-08-30
10603266534875Super BrushSuper Brush, LLCKXG2024-08-30
10603266541835Super BrushSuper Brush, LLCKXG2024-08-30
00842558116501BactiSwab (Dry) CS/500Remel Inc.KXG2024-08-14
58053326011509FLOQSwabs® COPAN ITALIA SPAKXG2024-07-02