Cervos Platelet Separator Triple Pack - CER-PRP-60-2 Platelet Triple Pack PN: 76114-01M - RANFAC CORP.

Duns Number:121622872

Device Description: CER-PRP-60-2 Platelet Triple Pack PN: 76114-01M

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More Product Details

Catalog Number

CER-PRP-60-2

Brand Name

Cervos Platelet Separator Triple Pack

Version/Model Number

CER-PRP-60-2

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

BK200543,BK200543

Product Code Details

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Device Record Status

Public Device Record Key

88540b67-bd02-43b3-9dee-00144f0d9c67

Public Version Date

October 05, 2021

Public Version Number

1

DI Record Publish Date

September 27, 2021

Additional Identifiers

Package DI Number

10850023741278

Quantity per Package

10

Contains DI Package

00850023741271

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"RANFAC CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 93