HARVEST® - Platelet Concentrate (PC) Procedure Pack - TERUMO BCT, INC.

Duns Number:801679200

Device Description: Platelet Concentrate (PC) Procedure Pack

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More Product Details

Catalog Number

-

Brand Name

HARVEST®

Version/Model Number

51401

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK120038,BK120038

Product Code Details

Product Code

ORG

Product Code Name

Platelet and plasma separator for bone graft handling

Device Record Status

Public Device Record Key

9215af52-6079-4b0e-9eb8-f746857bbffe

Public Version Date

September 02, 2022

Public Version Number

8

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

35020583514011

Quantity per Package

4

Contains DI Package

05020583514010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"TERUMO BCT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 27