FDA.reportPublic FDA data

IEC-Innoview GmbH

Primary DI
B192300008000
Brand
IEC-Innoview GmbH
Company
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
Model
30-0008-00
Catalog number
30-0008-00
Device description
2.7 mm, 30 deg. Arthroscope, l=187.5mm, autoclavable
Published
2016-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962330000AMO ARTHOSCOPESAmerican Microptiks, Inc.1996-09-11HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B192300008000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid 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 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle30degree
Length187.5Millimeter
Outer Diameter2.7Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
010741028
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B192300003000IEC-Innoview GmbH30-0003-0030-0003-002016-05-31
B192300004000IEC-Innoview GmbH30-0004-0030-0004-002016-05-23
B192300006000IEC-Innoview GmbH30-0006-0030-0006-002016-05-23
B192300010000IEC-Innoview GmbH30-0010-0030-0010-002016-05-23
B192300011000IEC-Innoview GmbH30-0011-0030-0011-002016-05-24
B192300012000IEC-Innoview GmbH30-0012-0030-0012-002016-05-24
B192300054000IEC-Innoview GmbH30-0054-0030-0054-002016-06-02
B192300055000IEC-Innoview GmbH30-0055-0030-0055-002016-05-24
B192300057000IEC-Innoview GmbH30-0057-0030-0057-002016-05-24
B192300068000IEC-Innoview GmbH30-0068-0030-0068-002016-07-12
B192300311000IEC-Innoview GmbH30-0311-0030-0311-002016-05-24
B192300346000IEC-Innoview GmbH30-0346-0030-0346-002016-05-24
B192300348000IEC-Innoview GmbH30-0348-0030-0348-002016-05-24
B192300421000IEC-Innoview GmbH30-0421-0030-0421-002016-05-24
B192300514000IEC-Innoview GmbH30-0514-0030-0514-002016-05-26
B192300515000IEC-Innoview GmbH30-0515-0030-0515-002016-05-26
B192300646000IEC-Innoview GmbH30-0646-0030-0646-002016-07-12
B1921091313550Eberle10-91313-5510-91313-552023-06-08
B192300048000IEC-Innoview GmbH30-0048-0030-0048-002023-06-08
B192300049000IEC-Innoview GmbH30-0049-0030-0049-002023-06-08

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