INTRECTOR® - INTRECTOR® Power Unit for use with the INTRECTOR® - INSIGHT INSTRUMENTS, INC.

Duns Number:828348391

Device Description: INTRECTOR® Power Unit for use with the INTRECTOR® Portable Vitrectomy System REF: 71200

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More Product Details

Catalog Number

71102

Brand Name

INTRECTOR®

Version/Model Number

71102

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)

Yes

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

HKP

Product Code Name

Instrument, Vitreous Aspiration And Cutting, Battery-Powered

Device Record Status

Public Device Record Key

ecf3bfaa-f427-40bb-9236-1261929c814a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSIGHT INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 8