ScleralTrack Needle - For administrating local anesthetics prior to - HURRICANE MEDICAL INC

Duns Number:093377724

Device Description: For administrating local anesthetics prior to ophthalmic surgery.

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More Product Details

Catalog Number

1525

Brand Name

ScleralTrack Needle

Version/Model Number

1525

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)

Yes

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

-

Product Code Details

Product Code

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Device Record Status

Public Device Record Key

61863f11-7def-4294-a1a4-1b937c987e2e

Public Version Date

April 07, 2020

Public Version Number

2

DI Record Publish Date

January 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HURRICANE MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 75