FDA.reportPublic FDA data

EndoTBasket

Primary DI
00816207021386
Brand
EndoTBasket
Company
ENDO-THERAPEUTICS, INC.
Model
ET2046
Catalog number
ET2046
Device description
Endoscopic retrieval device, small hexagonal basket
Published
2025-02-26
Public version status
New
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
OCZEndoscopic Grasping/Cutting Instrument, Non-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K800970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800970000M.R. ASSOC. BASKET RETRIEVERSMr Associates, Inc.1980-05-08OCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816207021383PackageGS11In Commercial Distribution
00816207021386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081620702138310816207021383
00816207021386008162070213868162070213860816207021386

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/airway foreign body retrieval basket, single-useA flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). It is typically designed with a long, thin, flexible body that has an expandable basket at the distal end in which objects are caught for extraction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length220Centimeter
Outer Diameter1.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
844-400-3636customerservice@endotherapeutics.com

Regulatory Flags#

DUNS number
825239189
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816207021775Biopsy BrushET1424ET14242026-10-07
00816207021782Biopsy BrushET1425ET14252026-10-07
00816207020006EndoTBasketET2031ET20312016-09-22
00816207020013EndoTBasketET2030ET20302016-09-22
00816207020020EndoTBasketET2033ET20332016-09-22
00816207020037EndoTBasketET2032ET20322016-09-22
00816207020044EndoTBasketET2035ET20352016-09-22
00816207020051EndoTBasketET2034ET20342016-09-22
00816207020068EndoTBasketET2040ET20402016-09-22
00816207020075EndoTBasketET2041ET20412016-09-22
00816207020082EndoTBasketET2043ET20432016-09-22
00816207020099EndoTBasketET2042ET20422016-09-22
00816207020112EndoTBasketET2045ET20452016-09-22
00816207020129EndoTBasketET2044ET20442016-09-22
00816207020334EndoTGrasperET2021ET20212016-09-22
00816207020341EndoTGrasperET2022ET20222016-09-22
00816207020952EndoTGrasperET2020ET20202022-09-21
00816207021027Single Use Brush Biopsy InstrumentEGD-160-006EGD-160-0062022-12-09
00816207021041Single Use Brush Biopsy InstrumentEGD-230-006EGD-230-0062022-12-09
00816207021690Single Use Brush Biopsy InstrumentTNE-110TNE-1102022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083048006SimpleSnipENVISION ENDOSCOPY, INC.OCZ2026-07-17
00850083048068SimpleSnipENVISION ENDOSCOPY, INC.OCZ2026-07-17
04953170466137Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
04953170466144Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
04953170466151Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
04953170466168Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466134Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466141Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466158Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
14953170466165Single Use Retrieval Basket VOLYMPUS MEDICAL SYSTEMS CORP.OCZ2025-03-25
10816207021383EndoTBasketENDO-THERAPEUTICS, INC.OCZ2025-02-26
04260206311706stentfix OTSC System SetOvesco Endoscopy Usa, Inc.OCZ2024-09-13
00860001219821ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219845ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219852ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
00860001219838ENSIZORSLATER ENDOSCOPY LLCOCZ2023-08-11
04055207027820HYSAFERichard Wolf GmbHOCZ2023-01-10
04055207028940HYSAFERichard Wolf GmbHOCZ2023-01-10
04055207028957HYSAFERichard Wolf GmbHOCZ2023-01-10
04055207041130HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028902HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027783HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027790HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027806HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207027813HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028858HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028865HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028872HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028889HYSAFERichard Wolf GmbHOCZ2023-01-03
04055207028926HYSAFERichard Wolf GmbHOCZ2023-01-03