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

Joint, Ankle, External Brace (ITW) (10)

Premarket Exempt

Yes

Clear

BMI - G088AFORLSB0 Catalog Number : AFO-RL-SB

Device Description : Ankle/Foot Orthosis, size Regular/Large (Shortback version)

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFORSB0 Catalog Number : AFO-R-SB

Device Description : Ankle/Foot Orthosis, size Regular (Shortback version)

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFORX0 Catalog Number : AFO-RX

Device Description : Ankle/Foot Orthosis, size Regular/Extra Large

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFORXSB0 Catalog Number : AFO-RX-SB

Device Description : Ankle/Foot Orthosis, size Regular/Extra Large (Shortback version)

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOX0 Catalog Number : AFO-X

Device Description : Ankle/Foot Orthosis, size Extra Large

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOXE0 Catalog Number : AFO-XE

Device Description : Ankle/Foot Orthosis, size Extra Large-Edema

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOXESB0 Catalog Number : AFO-XE-SB

Device Description : Ankle/Foot Orthosis, size Extra Large/Edema (Shortback version)

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOXL0 Catalog Number : AFO-XL

Device Description : Ankle/Foot Orthosis, size Extra Large/Large

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOXLSB0 Catalog Number : AFO-XL-SB

Device Description : Ankle/Foot Orthosis, size Extra Large/Large (Shortback version)

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOXR0 Catalog Number : AFO-XR

Device Description : Ankle/Foot Orthosis, size Extra Large/Regular

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

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