Samco Clicktainer - 120ML/53MMCLK O/R PCH ORCAP ST - Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.

Duns Number:813622313

Device Description: 120ML/53MMCLK O/R PCH ORCAP ST

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More Product Details

Catalog Number

-

Brand Name

Samco Clicktainer

Version/Model Number

120ORG53-4000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 28, 2022

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

FMH

Product Code Name

CONTAINER, SPECIMEN, STERILE

Device Record Status

Public Device Record Key

83adfc22-03e6-4c39-8c96-8dbd0b1a5d0e

Public Version Date

August 09, 2022

Public Version Number

2

DI Record Publish Date

September 09, 2018

Additional Identifiers

Package DI Number

37503025060218

Quantity per Package

100

Contains DI Package

17503025060214

Package Discontinue Date

July 28, 2022

Package Status

Not in Commercial Distribution

Package Type

Case

"THERMO FISHER SCIENTIFIC (MONTERREY), S. DE R.L. DE C.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10