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 - G088DSECOSL0 Catalog Number : DS-ECO-SL

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECOSR0 Catalog Number : DS-ECO-SR

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECOXL0 Catalog Number : DS-ECO-XL

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECOXR0 Catalog Number : DS-ECO-XR

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECOXXL0 Catalog Number : DS-ECO-XXL

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSECOXXR0 Catalog Number : DS-ECO-XXR

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSESOLL0 Catalog Number : DS-ESO-LL

Device Description : Panacea Static Elbow orthosis, size Large/Large

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSESOLM0 Catalog Number : DS-ESO-LM

Device Description : Panacea Static Elbow orthosis, size Large/Medium

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSESOLS0 Catalog Number : DS-ESO-LS

Device Description : Panacea Static Elbow orthosis, size Large/Small

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Panacea - G088DSESOMM0 Catalog Number : DS-ESO-MM

Device Description : Panacea Static Elbow orthosis, size Medium/Medium

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

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