FDA.reportPublic FDA data

AVANOS

Primary DI
10350770927647
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
92764
Catalog number
60634
Device description
Foreign Body Grasping Forceps
Published
2019-09-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCZEndoscopic grasping/cutting instrument, non-powered
PTSEndoscopic grasping/cutting instrument, non-powered, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K874004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874004000ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125)Endovations1987-12-29OCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350770927647PackageGS15In Commercial Distribution
00350770927640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077092764710350770927647
00350770927640003507709276403507709276400350770927640

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic stone-retrieval forceps, single-useA flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a flexible metal coil or plastic tube whose distal end is equipped with a pair of thin grasping claws in which the stone is seized and held for extraction. The claws are operated by a control handle at the proximal end of the instrument. 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
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1095816020630-202026-10-20
00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1095818020630-242026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095822020640-142026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1095823020640-202026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1095824020640-242026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095828020644-142026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1095829020644-202026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1095830020644-242026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1095832020645-202026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1095833020645-242026-10-20
00350770008998100mL ENFit GPro Syringe Purple Sterile120008323PNM-S100NCV2026-10-19
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1200011280630-142026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1200011290630-202026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1200014300630-242026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1095814020630-142026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014310640-142026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014320640-202026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014330640-242026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014340644-142026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014350644-202026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603215401Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603215418Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603215579Disposable Grasping ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603215586Disposable Grasping ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603222492Disposable Grasping ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603222508Disposable Grasping ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603237281Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603237298Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603237304Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06936603237311Kyatchi NetYangzhou Fartley Medical Instrument Technology Co., LtdPTS2026-10-22
06959664944677NAHangzhou AGS MedTech Co., Ltd.PTS2026-08-21
00858836007126DiLumen Interventional GrasperLUMENDI LLCPTS2026-08-07
00850083048006SimpleSnipENVISION ENDOSCOPY, INC.OCZ2026-07-17
00850083048068SimpleSnipENVISION ENDOSCOPY, INC.OCZ2026-07-17
00810116023943Dornier MedTech DORNIER MEDTECH AMERICA, INC.PTS2026-04-17
00816207021744EndoTExtractorENDO-THERAPEUTICS, INC.PTS2026-03-03
00850025860628Rotatable Grasping ForcepMicro-tech UsaPTS2025-03-04
00816207021386EndoTBasketENDO-THERAPEUTICS, INC.OCZ2025-02-26
00860001219821ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219845ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
04055207041130HYSAFERichard Wolf GmbHOCZ2023-01-03
00860009064720g-Prox EZ Endoscopic GrasperUsgi Medical, Inc.OCZ2022-12-20
00860009064737g-Prox EZ Endoscopic GrasperUsgi Medical, Inc.OCZ2022-12-20
00816207020952EndoTGrasperENDO-THERAPEUTICS, INC.OCZ2022-09-21
00724995217044RaptorUS EndoscopyPTS2022-03-18
00724995180614CentraUS EndoscopyPTS2021-03-31
00724995180621CentraUS EndoscopyPTS2021-03-31
00724995180638CentraUS EndoscopyPTS2021-03-31
00724995180645CentraUS EndoscopyPTS2021-03-31
00858836007102DiLumen Interventional GrasperLUMENDI LLCPTS2020-08-25