FDA.reportPublic FDA data

Foreign Body Retrieval Basket

Primary DI
00350770927657
Brand
Foreign Body Retrieval Basket
Company
Avanos Medical, Inc.
Model
92765
Catalog number
60717
Device description
Foreign Body Retrieval Basket
Published
2019-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10350770927654PackageGS15In Commercial Distribution
00350770927657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035077092765410350770927654
00350770927657003507709276573507709276570350770927657

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.

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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