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
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31
00812120005120Game Ready* Ankle Wrap, Extra Large120008550590340-042026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, Right120008551590422-042026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, Left120008552590424-042026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, Right120008553590432-042026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, Left120008554590434-042026-07-31
00812120005175Game Ready* Back Wrap120008555590500-042026-07-31
00812120005182Game Ready* C-T Spine Wrap, Large120008556590502-042026-07-31
00812120005199Game Ready* Hip/Groin Wrap, Right120008557590602-042026-07-31
00812120005205Game Ready* Hip/Groin Wrap, Left120008558590604-042026-07-31
00812120005212Game Ready* Hand/Wrist Wrap120008559590811-042026-07-31
00812120005229Game Ready* Flexed Elbow Wrap120008560590903-042026-07-31
00812120005236Game Ready* Half Leg Boot Wrap120008561590906-042026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, Large120008562590922-042026-07-31
00812120005250Game Ready* Straight Knee Sleeve120009290510100-042026-07-31
00812120005267Game Ready* Articulated Knee Sleeve120009291510160-042026-07-31
00812120005274Game Ready* Straight Elbow Sleeve120009292510200-042026-07-31
00812120005281Game Ready* Ankle Sleeve, Large120009293510330-042026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06934415029926ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029933ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029940ZKSKBeijing 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