Sure-Vue - SURE-VUE HCG STAT SER/UR 50/PK - FISHER SCIENTIFIC COMPANY L.L.C.

Duns Number:004321519

Device Description: SURE-VUE HCG STAT SER/UR 50/PK

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More Product Details

Catalog Number

23900531

Brand Name

Sure-Vue

Version/Model Number

4581405021

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)

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

JHI

Product Code Name

Visual, pregnancy hCG, prescription use

Device Record Status

Public Device Record Key

3fa0f5bb-06f8-4fac-a975-7761a8d22c4d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FISHER SCIENTIFIC COMPANY L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 129
2 A medical device with a moderate to high risk that requires special controls. 36