FDA.reportPublic FDA data

AVANOS

Primary DI
10350770926596
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
92659
Catalog number
60317
Device description
Cytology Brush
Published
2019-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDXendoscopic cytology brush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDXEndoscopic Cytology BrushGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941464000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941464000BASICS ENDOSCOPY SYSTEMCox Medical Ent., Inc.1994-08-05OCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770926596PackageGS110In Commercial Distribution
00350770926599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077092659610350770926596
00350770926599003507709265993507709265990350770926599

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning brush/tool, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15
00350770008929NEOMED* Oral / Enteral Syringe with ENFit® Connector120004842BP-S12NC2026-08-15
00350770008943NEOMED* Oral / Enteral Syringe with ENFit® Connector120004847BP-S60NC2026-08-15
00350770008967NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004849NEO122026-08-15
00350770008981NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004852NEO602026-08-15
00350770009001NEOMED* Oral / Enteral Syringe with ENFit® Connector120004832BA-S12NC-S2026-08-15
00350770009018NEOMED* Oral / Enteral Syringe with ENFit® Connector120004869PNM-S12NC2026-08-15
00350770009032NEOMED* Oral / Enteral Syringe with ENFit® Connector120004874PNM-S35NC2026-08-15
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170466212Single Use Cytology Brush VOLYMPUS MEDICAL SYSTEMS CORP.FDX2026-01-19
14953170466219Single Use Cytology Brush VOLYMPUS MEDICAL SYSTEMS CORP.FDX2026-01-19
00816207021751EndoTBrush Cytology BrushENDO-THERAPEUTICS, INC.FDX2024-04-18
10816207021758EndoTBrush Cytology BrushENDO-THERAPEUTICS, INC.FDX2024-04-18
00813353010295Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010301Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010318Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010325Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010332Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010349Disposable Gastrointestinal Cytology BrushTelemed SystemsFDX2023-08-24
00813353010356Disposable Bronchial Cytology BrushTelemed SystemsFDX2023-08-24
00813353010363Disposable Bronchial Cytology BrushTelemed SystemsFDX2023-08-24
10884521843219superDimensionCovidien LPFDX2023-07-22
20884521843216superDimensionCovidien LPFDX2023-07-22
10884521843172superDimensionCovidien LPFDX2023-07-21
20884521843179superDimensionCovidien LPFDX2023-07-21
06970401810703Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810710Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810727Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810734Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810741Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810758Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810765Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810772Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810789Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810796Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810802Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810819Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810826Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18
06970401810833Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., LTD.FDX2023-05-18