Blake Manufacturing, Inc.

Address:9241 LAZY LN.,TAMPA,FL,33614,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

Orthosis, Limb Brace (IQI) (10)

Premarket Exempt

Yes

Clear

Panacea - G088DSECELL0 Catalog Number : DS-ECE-LL

Device Description : Panacea Contracture Elbow orthosis, size Large/Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECELR0 Catalog Number : DS-ECE-LR

Device Description : Panacea Contracture Elbow orthosis, size Large/Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECERL0 Catalog Number : DS-ECE-RL

Device Description : Panacea Contracture Elbow orthosis, size Regular/Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECERR0 Catalog Number : DS-ECE-RR

Device Description : Panacea Contracture Elbow orthosis, size Regular/Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECESL0 Catalog Number : DS-ECE-SL

Device Description : Panacea Contracture Elbow orthosis, size Small/Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECESR0 Catalog Number : DS-ECE-SR

Device Description : Panacea Contracture Elbow orthosis, size Small/Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECOLL0 Catalog Number : DS-ECO-LL

Device Description : Panacea Elbow Corrective orthosis, size Large/Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECOLR0 Catalog Number : DS-ECO-LR

Device Description : Panacea Elbow Corrective orthosis, size Large/Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECOML0 Catalog Number : DS-ECO-ML

Device Description : Panacea Elbow Corrective orthosis, size Medium/Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECOMR0 Catalog Number : DS-ECO-MR

Device Description : Panacea Elbow Corrective orthosis, size Medium/Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

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