Titanium Curved Tying Forceps, 115mm - KATALYST SURGICAL LLC

Duns Number:007883297

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More Product Details

Catalog Number

-

Brand Name

Titanium Curved Tying Forceps, 115mm

Version/Model Number

3806-115

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

2a8550a5-faaf-474a-935e-b728e4db7a12

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

May 31, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KATALYST SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1640
2 A medical device with a moderate to high risk that requires special controls. 288