SRH3427LBlue Sky Bio, LLC - BIO Quattro Screw Impression Transfer - BLUE SKY BIO LLC

Duns Number:618960848

Device Description: BIO Quattro Screw Impression Transfer

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More Product Details

Catalog Number

-

Brand Name

SRH3427LBlue Sky Bio, LLC

Version/Model Number

SRQMS

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

EHY

Product Code Name

Tray, Impression, Preformed

Device Record Status

Public Device Record Key

214d1ec0-c9e9-4ac1-a1a1-f48807759ae0

Public Version Date

October 21, 2022

Public Version Number

2

DI Record Publish Date

July 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BLUE SKY BIO LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 591
2 A medical device with a moderate to high risk that requires special controls. 912