Q System Arthroscope - 3mm 30º Arthroscope - Orthopedic Sciences Inc

Duns Number:068109169

Device Description: 3mm 30º Arthroscope

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More Product Details

Catalog Number

AS-175S

Brand Name

Q System Arthroscope

Version/Model Number

AS-175S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133018

Product Code Details

Product Code

HRX

Product Code Name

ARTHROSCOPE

Device Record Status

Public Device Record Key

138751ee-efbb-4a53-bd16-5f9032d52643

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOPEDIC SCIENCES INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 117