FDA.reportPublic FDA data

AVANOS

Primary DI
10350770928101
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
92810
Catalog number
69392
Device description
* Foreign Body Retrieval Hood Protector
Published
2019-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEDendoscopic access overtube, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K841258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K841258000FOREIGN BODY PROTECTORJayco Pharmaceuticals1984-07-09FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770928101PackageGS110In Commercial Distribution
00350770928104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077092810110350770928101
00350770928104003507709281043507709281040350770928104

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning sponge/padA hand-held device in the form of a sponge or pad intended to be used for the pre-cleaning (i.e., removal of gross blood and other organic debris) of medical devices prior to disinfection or sterilization; it is not intended for use during a medical/surgical procedure. It may be soft or abrasive, and may contain non-medicated substances (e.g., enzymes, surfactant) to facilitate cleaning. 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
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770009148NeoMed120008812PNM-S35NC2026-07-21
00350770456096CLOG ZAPPER* with Applicator12000154520-00022019-06-21
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06973356551745TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551752TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551769TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551776TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551783TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06936345101536Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345101543Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104469Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104476Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104483Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104490Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104544Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06925816667213ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816667220ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816667237ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06970462547457Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547464Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547471Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547488Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547495Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547501Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547518Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547525Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547532Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547549Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547556Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10