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

Splint, Hand, And Components (ILH) (3) Orthosis, Limb Brace (IQI) (2)

Premarket Exempt

Yes

Clear

BMI - G088MSCFMR0 Catalog Number : MSC-FM-R

Device Description : Hyper Extension Mitt orthosis, size Regular

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088MSCPGL0 Catalog Number : MSC-PG-L

Device Description : Palm Guard - Left sided

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088MSCPGR0 Catalog Number : MSC-PG-R

Device Description : Palm Guard, Right sided

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088MSCSAL0 Catalog Number : MSC-SA-L

Device Description : Shoulder Abductor Pillow, side: Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

BMI - G088MSCSAR0 Catalog Number : MSC-SA-R

Device Description : Shoulder Abductor Pillow, side: Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

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