MICROTEK - ORTHOPEDIC SUCTION SYSTEM - Microtek Medical Inc.

Duns Number:106908437

Device Description: ORTHOPEDIC SUCTION SYSTEM

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More Product Details

Catalog Number

-

Brand Name

MICROTEK

Version/Model Number

1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Device Record Status

Public Device Record Key

171d2ea9-da30-406a-8f69-0d21f5f37d0a

Public Version Date

February 11, 2019

Public Version Number

3

DI Record Publish Date

November 04, 2016

Additional Identifiers

Package DI Number

30748426072973

Quantity per Package

5

Contains DI Package

00748426072972

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MICROTEK MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 919