MediChoice - Heelstick Infant Full-Term Incision Depth 1.00 - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Heelstick Infant Full-Term Incision Depth 1.00 Millimeter And Length 2.50 Millimeter Singl Heelstick Infant Full-Term Incision Depth 1.00 Millimeter And Length 2.50 Millimeter Single Use Sterile Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

MediChoice

Version/Model Number

MC5090

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"

Yes

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

FMK

Product Code Name

Lancet, blood

Device Record Status

Public Device Record Key

9d37489a-9e45-4e27-9b19-7e328e408b77

Public Version Date

October 27, 2020

Public Version Number

1

DI Record Publish Date

October 19, 2020

Additional Identifiers

Package DI Number

50885632134508

Quantity per Package

6

Contains DI Package

30885632134504

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1