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) (7)

Premarket Exempt

No Yes

Clear

Blue Sky Bio, LLC. - 00815131029932 Catalog Number :

Device Description : Drill Profile 5.0mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029949 Catalog Number :

Device Description : Drill Profile 6.0mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029956 Catalog Number :

Device Description : Drill Profile D 35mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029963 Catalog Number :

Device Description : Drill Profile D 4.0mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029970 Catalog Number :

Device Description : Drill Profile D 4.5mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029987 Catalog Number :

Device Description : Drill Profile D 5.0mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00815131029994 Catalog Number :

Device Description : Drill Profile H 3.7mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

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