FDA.reportPublic FDA data

ViziShot FLEX

Primary DI
00896506002132
Brand
ViziShot FLEX
Company
Gyrus Acmi, Llc
Model
NA-U402SX-4019
Device description
Single Use Aspiration Needle
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KTIBronchoscope Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTIBronchoscope AccessoryEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896506002132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896506002132008965060021328965060021320896506002132

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy handpiece/needleA sterile flexible device intended to be used to obtain tissue specimens, for histopathological examination, during various endoscopic procedures (e.g., bronchoscopy, gastroscopy). It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a biopsy needle which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the compatible endoscope. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117521967
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009698453161Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453178Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453185Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453208Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453215Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453222Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453239Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453246Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453192Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-19
00860009430242Adapter SRA-2-01 SERPEX MEDICAL INC.KTI2025-12-08
00860009430211Compass Steerable NeedleSERPEX MEDICAL INC.KTI2025-12-08
00860009430235Adapter SRA-1-01 SERPEX MEDICAL INC.KTI2025-12-08
10860009430249Adapter SRA-2-01 SERPEX MEDICAL INC.KTI2025-12-08
00816734023518BullDog®DIVERSATEK HEALTHCARE, INC.KTI2025-12-05
10816734023515BullDog®DIVERSATEK HEALTHCARE, INC.KTI2025-12-05
00850081350002Ion Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00850081350019Monarch Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
00850081350026Monarch Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00850081350033Olympus Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
00850081350040Olympus Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00860003935842EndoCorePRAXIS MEDICAL LLCKTI2025-11-06
00860003935859Ion Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
04953170458378Single Use Aspiration Needle NA-201SX-4021OLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458385Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458392Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458408Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458375Single Use Aspiration Needle NA-201SX-4021OLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458382Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458399Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458405Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14