FDA.reportPublic FDA data

Fistula Brush

Primary DI
04260206310631
Brand
Fistula Brush
Company
Ovesco Endoscopy AG
Model
Proctology
Catalog number
200.62
Device description
The Fistula Brush can be used for probing of the fistula tract and for debridement before using the OTSC Proctology • it is used to clean the fistula tract and remove granulation tissue • supports obliteration of fistula tract
Published
2016-09-16
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
4260206310280PackageGS15In Commercial Distribution
04260206310631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4260206310280042602063102804260206310280
04260206310631042602063106314260206310631

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose cytology brushA sterile device consisting of tufts or bristles set into a handle that is intended to collect cells from an area of the body, typically during an open surgical procedure. The cells are used for histopathological analysis. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49707196528160service@ovesco.com
+19196519449customerservice@ovesco-usa.com

Regulatory Flags#

DUNS number
344007369
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260206311966BougieCap PP400.402026-01-16
04260206311911AWCduo124 cm200.57.052025-06-05
04260206311935AWCduo184 cm200.57.062025-06-05
04260206310983BARS SetBARS Set100.602024-11-29
04260206310648Traction Polypectomy Snare220 cm200.55.102016-09-16
04260206311010colonic FTRD Set14200.702018-05-28
04260206311027Coag Dissector165 cm200.502018-07-05
04260206311034AqaNife1.5 mm200.53.012018-10-02
04260206311041AqaNife2.0 mm200.53.022018-10-02
04260206311058AqaNife2.5 mm200.53.032018-10-02
04260206311065AqaNife3.0 mm200.53.042018-10-02
04260206311072diagnostic FTRD Set13200.762018-10-02
04260206311003LiftUpLiftUp200.56.012022-08-22
04260206311355LiftUp KitLiftUp Kit200.56.022022-08-22
04260206311263BARS Anchor silver165 cm200.122022-11-22
04260206311270BARS Anchor black165 cm200.132022-11-22
04260206310143OTSC Anchor165 cm200.102016-09-16
04260206310228OTSC Twin Grasper165 cm200.442016-09-16
04260206310235OTSC Twin Grasper220 cm200.452016-09-16
04260206310273OTSC Proctology Anchor38 cm200.612016-09-16

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