Oph.Forceps - Nichamin II Lens Insert Fcps, Titanium - KATENA PRODUCTS, INC.

Duns Number:085668598

Device Description: Nichamin II Lens Insert Fcps, Titanium

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

05-2348

Brand Name

Oph.Forceps

Version/Model Number

05-2348

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

HNR

Product Code Name

Forceps, ophthalmic

Device Record Status

Public Device Record Key

dd298830-d73c-408a-99eb-f032ddf7a082

Public Version Date

September 22, 2020

Public Version Number

1

DI Record Publish Date

September 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KATENA PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1518
2 A medical device with a moderate to high risk that requires special controls. 26
U Unclassified 63