Catalog Number

LP7510AT

Brand Name

SURGISTAR

Version/Model Number

960012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K923689,K923689,K923689,K923689

Product Code

GDX

Product Code Name

Scalpel, One-Piece

Public Device Record Key

775c8d16-8ef1-43ff-8654-1c0e6f76cc71

Public Version Date

January 22, 2021

Public Version Number

6

DI Record Publish Date

July 07, 2016

Package DI Number

10878799004182

Quantity per Package

6

Contains DI Package

00878799004185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-