FDA.reportPublic FDA data

Single Use Brush Biopsy Instrument

Primary DI
00816207021041
Brand
Single Use Brush Biopsy Instrument
Company
ENDO-THERAPEUTICS, INC.
Model
EGD-230-006
Catalog number
EGD-230-006
Device description
WATS Biopsy Instrument for Computer Assisted 3D Analysis
Published
2022-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEEBrush, Biopsy, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEEBrush, Biopsy, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816207021041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816207021041008162070210418162070210410816207021041

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic cytology brush, single-useA device intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816207021690Single Use Brush Biopsy InstrumentTNE-110TNE-1102022-12-09
00816207021706Single Use Brush Biopsy InstrumentTNL-80TNL-802022-12-09
00816207021713Single Use Brush Biopsy InstrumentWGB-200-006WGB-200-0062022-12-09
00816207021744EndoTExtractorET2070ET20702026-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850068304851SBHSBH SurgicalGEE2026-05-08
00190776420970MillenniumAvalign Technologies, Inc.GEE2026-04-30
00860011506348SWAB-PAKMedical Packaging CorporationGEE2026-02-18
00860011506355SWAB-PAKMedical Packaging CorporationGEE2026-02-18
00816207021720Biopsy BrushENDO-THERAPEUTICS, INC.GEE2025-02-26
06971317521769StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
06971317521776StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
16971317521766StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
16971317521773StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
00190776300708MillenniumAvalign Technologies, Inc.GEE2023-11-15
00190776301637MillenniumAvalign Technologies, Inc.GEE2023-11-15
00816207021027Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021690Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021706Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00816207021713Single Use Brush Biopsy InstrumentENDO-THERAPEUTICS, INC.GEE2022-12-09
00190776198176MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198183MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198190MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198206MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198213MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198220MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198237MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198244MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198251MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198268MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198275MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198282MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198299MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198305MillenniumAvalign Technologies, Inc.GEE2021-11-02
00190776198312MillenniumAvalign Technologies, Inc.GEE2021-11-02