Blue Sky Bio, LLC - Driver Hex .050 Long - BLUE SKY BIO LLC

Duns Number:618960848

Device Description: Driver Hex .050 Long

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More Product Details

Catalog Number

-

Brand Name

Blue Sky Bio, LLC

Version/Model Number

SDL050

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

-

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

EBL

Product Code Name

Pin, Retentive And Splinting, And Accessory Instruments

Device Record Status

Public Device Record Key

4d3c8a4b-904e-41db-9eb6-877c12e45c61

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