BLUE SKY BIO LLC

Address:800 Liberty Drive,Libertyville,IL,60048,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pin, Retentive And Splinting, And Accessory Instruments (EBL) (10)

Premarket Exempt

No Yes

Clear

Blue Sky Bio, LLC. - 00815131029833 Catalog Number :

Device Description : Drill N Implant 3.5, 3.7 Short

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029840 Catalog Number :

Device Description : Drill N Implant 4.3 Long

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029857 Catalog Number :

Device Description : Drill N Implant 4.3 Short

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029864 Catalog Number :

Device Description : Drill N Implant 5.0 Long

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029871 Catalog Number :

Device Description : Drill N Implant 5.0 Short

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029888 Catalog Number :

Device Description : Drill N Implant 6.0 Short

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029895 Catalog Number :

Device Description : Drill N Starter Long

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029901 Catalog Number :

Device Description : Drill N Starter Short

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029918 Catalog Number :

Device Description : Drill Profile 3.5mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029925 Catalog Number :

Device Description : Drill Profile 4.3mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

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