FDA.reportPublic FDA data

AccessVu 60

Primary DI
00850023905017
Brand
AccessVu 60
Company
INTRAVU, INC.
Model
IV-ASY-1606
Catalog number
IV-ASY-1606
Device description
Disposable accessory kit to be used with IntraVu Scope 60.Kit contains 60mm cannula, 60mm trocar, cannula cap and stopcock.
Published
2021-10-15
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
GCJLaparoscope, General & Plastic Surgery
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181982000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181982000MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.2018-08-21HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850023905017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850023905017008500239050178500239050170850023905017

GMDN Terms#

Term, Definition table
TermDefinition
Rigid arthroscope, single-useA sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint [e.g., knee, shoulder, elbow, temporomandibular joint (TMJ)]. It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18774977705ProductInfo@IntraVu.com

Regulatory Flags#

DUNS number
116708692
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0085002390503130 SideVu-60IV-ASY-3060IV-ASY-30602023-07-03
0085002390504830 SideVu-90IV-ASY-3090IV-ASY-30902023-07-03
0085002390505530 SideVu-120IV-ASY-3120IV-ASY-31202023-07-03
00850023905000AccessVu 90IV-ASY-1609IV-ASY-16092021-10-15
00850023905024AccessVu 120IV-ASY-1612IV-ASY-16122021-10-15
00865351000341IntraVu Scope 120IV-ASY-1120IV-ASY-11202019-12-02
00865351000358IntraVu Scope 90IV-ASY-1090IV-ASY-10902019-12-02
00865351000365IntraVu Scope 60IV-ASY-1060IV-ASY-10602019-12-02
00865351000303MIDAScope™ - 120 and Introducer KitIV-ASY-0600IV-ASY-06002019-01-18
00865351000327MIDAScope™ - 90 and Introducer KitIV-ASY-0700IV-ASY-07002019-01-18
00865351000334MIDAScope™ - 60 and Introducer KitIV-ASY-0800IV-ASY-08002019-01-18
00865351000389TabletVuIV-ASY-2000IV-ASY-20002021-10-15
00865351000372IntraVu TabletIV-ASY-1000IV-ASY-10002019-12-02
00865351000310MIDASystem™ IV-ASY-0450IV-ASY-04502019-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08809281659387BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2026-05-11
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
08809281659301BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659325BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25
08800038058187SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038058200SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038057906MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057913MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057920MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057937MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057944MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
08800038056305SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056312SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056329SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056336SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056343SYNTH™ CDSIMEDICOM CO., LTD.HRX2023-10-31
08800038056145SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056152SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056169SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056176SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19