FDA.reportPublic FDA data

AVANOS

Primary DI
10350770927685
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
92768
Catalog number
60727
Device description
Foreign Body Retrieval Basket
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
FDXendoscopic cytology brush
PTSEndoscopic grasping/cutting instrument, non-powered, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDXEndoscopic Cytology BrushGastroenterology, Urology2
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, 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
10350770927685PackageGS15In Commercial Distribution
00350770927688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077092768510350770927685
00350770927688003507709276883507709276880350770927688

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic stone-retrieval forceps, reusableA rigid manual device intended to be inserted through the working channel of a compatible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a very long instrument with one sliding and one stationary rod, or a sheath, whose distal ends are equipped with thin grasping claws in which the stone is seized and held for extraction. The claws are typically operated by scissors-like ring handles at the proximal end of the instrument. This is a reusable 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
10680651135718Halyard13571PM0062016-08-10
10680651136128Halyard13612PM0022016-08-10
10680651136135Halyard13613PM0032016-08-10
10680651136142Halyard13614PM0042016-08-10
10680651136159Halyard13615PM0052016-08-10
00193494135713ON-Q* Pain Relief System13571PM0062020-05-07
00193494136123ON-Q* Pain Relief System13612PM0022020-05-07
00193494136130ON-Q* Pain Relief System13613PM0032020-05-07
00193494136147ON-Q* Pain Relief System13614PM0042020-05-07
00193494136154ON-Q* Pain Relief System13615PM0052020-05-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664944677NAHangzhou AGS MedTech Co., Ltd.PTS2026-08-21
00858836007126DiLumen Interventional GrasperLUMENDI LLCPTS2026-08-07
06934415028424ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029865ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029872ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029889ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029896ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029902ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029919ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
00810116023943Dornier MedTech DORNIER MEDTECH AMERICA, INC.PTS2026-04-17
00816207021744EndoTExtractorENDO-THERAPEUTICS, INC.PTS2026-03-03
04953170466212Single Use Cytology Brush VOLYMPUS MEDICAL SYSTEMS CORP.FDX2026-01-19
06926839810846AnreiAnrei Medical(HZ) Co.,Ltd.PTS2025-07-03
05708265014118LiNA CystoVu™ HD GrasperLina Medical ApSPTS2025-04-18
00850025860628Rotatable Grasping ForcepMicro-tech UsaPTS2025-03-04
00816207021751EndoTBrush Cytology BrushENDO-THERAPEUTICS, INC.FDX2024-04-18
04953170463648Single Use Loop Cutter FS-410OLYMPUS MEDICAL SYSTEMS CORP.PTS2024-03-25
10884521843219superDimensionCovidien LPFDX2023-07-22
10884521843172superDimensionCovidien LPFDX2023-07-21
06932503561075Grasping ForcepsMicro-Tech (Nanjing) Co., Ltd.PTS2023-06-28
00724995217044RaptorUS EndoscopyPTS2022-03-18
06932503549011Cytology BrushMicro-Tech (Nanjing) Co., Ltd.FDX2021-12-31
06932503549028Cytology BrushMicro-Tech (Nanjing) Co., Ltd.FDX2021-12-31
06932503549035Cytology BrushMicro-Tech (Nanjing) Co., Ltd.FDX2021-12-31
06932503549042Cytology BrushMicro-Tech (Nanjing) Co., Ltd.FDX2021-12-31
06932503549059Cytology BrushMicro-Tech (Nanjing) Co., Ltd.FDX2021-12-31
06932503549066Cytology BrushMicro-Tech (Nanjing) Co., Ltd.FDX2021-12-31
06932503549073Cytology BrushMicro-Tech (Nanjing) Co., Ltd.FDX2021-12-31
10653405052302CONMEDConmed CorporationFDX2021-08-20
10653405052319CONMEDConmed CorporationFDX2021-08-20