Catalog Number

0694-002-006

Brand Name

SURGICOUNT

Version/Model Number

0694002006

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LWH

Product Code Name

Counter, sponge, surgical

Public Device Record Key

dfd9b2e7-b714-4cc1-b60d-559cc0b06d05

Public Version Date

July 16, 2021

Public Version Number

1

DI Record Publish Date

July 08, 2021

Package DI Number

57613327517977

Quantity per Package

9

Contains DI Package

37613327517973

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case