Hayden Medical - Deitz ICL Manipulator Vertical blunt Y-shaped - Hayden Medical, Inc.

Duns Number:618214410

Device Description: Deitz ICL Manipulator Vertical blunt Y-shaped tip, angled 11mm from bend to tip, round knu Deitz ICL Manipulator Vertical blunt Y-shaped tip, angled 11mm from bend to tip, round knurled handle, 120mm overall length, stainless steel

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More Product Details

Catalog Number

E3-2695

Brand Name

Hayden Medical

Version/Model Number

E3-2695

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

af511aa1-4208-4f60-ad9f-27d9301e86f4

Public Version Date

August 24, 2022

Public Version Number

1

DI Record Publish Date

August 16, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HAYDEN MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2893
2 A medical device with a moderate to high risk that requires special controls. 195