FDA.reportPublic FDA data

Nuvis

Primary DI
08538160080010
Brand
Nuvis
Company
INTEGRATED ENDOSCOPY, INC.
Model
140-4010-1
Catalog number
140-4010-1
Device description
The NuVis™ Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, and feet joints. Integrated Endoscopy’s NuVis Arthroscope has a 140mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 140mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized.
Published
2018-02-08
Public version status
Update
Distribution status
Not 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
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140903000NUVIS ARTHROSCOPEIntegrated Endoscopy, Inc.2014-07-17HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08538160080027PackageGS110Not in Commercial Distribution
08538160080010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08538160080027085381600800278538160080027
08538160080010085381600800108538160080010

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical arthroscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle30degree
Length140Millimeter
Outer Diameter4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius90 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
17149552400tom@pinnaclemedtech.com

Regulatory Flags#

DUNS number
127632602
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853816008001NuvisIE4030IE40302020-03-30
10853816008008NuvisIE4030-10IE4030-102020-03-30
00853816008018NuvisIE58CAN-2IE58CAN-22020-03-30
00853816008025NuvisIE58CAN-1IE58CAN-12020-03-30
00853816008032NuvisIE58OBIE58OB2020-03-30
00853816008049NuvisIE58TRIE58TR2020-03-30
08538160080027Nuvis140-4010-1140-4010-12018-02-08

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