NA - 25 Gauge Vitreous Cutter, SP, w/ 79” Posterior - MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

Duns Number:790265227

Device Description: 25 Gauge Vitreous Cutter, SP, w/ 79” Posterior Tubing Set, Sterile, Single Use

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More Product Details

Catalog Number

2440CE

Brand Name

NA

Version/Model Number

2440CE

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102222,K102222

Product Code Details

Product Code

HQE

Product Code Name

Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Device Record Status

Public Device Record Key

28b6219c-4d80-4650-a64c-6b52e20160ad

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10812480010083

Quantity per Package

6

Contains DI Package

00812480010086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 30