FDA.reportPublic FDA data

ViziShot 2 FLEX

Primary DI
00821925043060
Brand
ViziShot 2 FLEX
Company
Gyrus ACMI, LLC
Model
NA-U403SX-4019
Device description
SINGLE USE ASPIRATION NEEDLE
Published
2020-09-23
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

Product Codes#

Code, Name table
CodeName
KTIBronchoscope accessory

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163469000ViziShot 2 FLEXOlympus Surgical Technologies America2017-04-06KTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925043060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925043060008219250430608219250430600821925043060

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925019157VOCOM1430002015-10-24
00821925019164GYRUS ACMI, INC1430012015-10-24
00821925019171GYRUS ACMI, INC1430022015-10-24
00821925019225GYRUS ACMI, INC1430062015-10-24
00821925019232GYRUS ACMI, INC1430072015-10-24
00821925019249GYRUS ACMI, INC1430082015-10-24
00821925019300GYRUS ACMI, INC1430032015-10-24
00821925019317GYRUS ACMI, INC1430042015-10-24
00821925019324GYRUS ACMI, INC1430052015-10-24
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10

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
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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