Titanium Straight Suturing Forceps, 0.10mm Teeth, 85mm - KATALYST SURGICAL LLC

Duns Number:007883297

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More Product Details

Catalog Number

-

Brand Name

Titanium Straight Suturing Forceps, 0.10mm Teeth, 85mm

Version/Model Number

3600S-10-85

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

9ef166db-d042-4da4-875e-575e4bd7e8c0

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

May 30, 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