SURGISTAR - SURGISTAR, INC.

Duns Number:808865125

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More Product Details

Catalog Number

LP7593G

Brand Name

SURGISTAR

Version/Model Number

885567

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

Yes

Prescription Use (Rx)

-

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

EMF

Product Code Name

Knife, Surgical

Device Record Status

Public Device Record Key

88fdb5d7-81ec-4b10-bd13-4dea0ffc6116

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

July 29, 2016

Additional Identifiers

Package DI Number

10878799009262

Quantity per Package

6

Contains DI Package

00878799009265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SURGISTAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 757
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 6