Blake Manufacturing, Inc.

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 - G088AFOE0 Catalog Number : AFO-E

Device Description : Ankle/Foot Orthosis, size Edema

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOEL0 Catalog Number : AFO-EL

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOELSB0 Catalog Number : AFO-EL-SB

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOER0 Catalog Number : AFO-ER

Device Description : Ankle/Foot Orthosis, size Edema/Regular

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOERSB0 Catalog Number : AFO-ER-SB

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOESB0 Catalog Number : AFO-E-SB

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOEX0 Catalog Number : AFO-EX

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOEXSB0 Catalog Number : AFO-EX-SB

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOL0 Catalog Number : AFO-L

Device Description : Ankle/Foot Orthosis, size Large

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOLE0 Catalog Number : AFO-LE

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

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