LEWICKY LENS MANIPULATING HOOK - LEWICKY LENS MANIPULATING HOOK BLUNT ANGLED TIP - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: LEWICKY LENS MANIPULATING HOOK BLUNT ANGLED TIP CURVED SHANK

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More Product Details

Catalog Number

1333471

Brand Name

LEWICKY LENS MANIPULATING HOOK

Version/Model Number

1333471

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

HNQ

Product Code Name

Hook, Ophthalmic

Device Record Status

Public Device Record Key

e6a569e4-9e6f-4d04-811c-c0fd64492872

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

October 08, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414