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 - G088AFOLESB0 Catalog Number : AFO-LE-SB

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOLR0 Catalog Number : AFO-LR

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOLRSB0 Catalog Number : AFO-LR-SB

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOLSB0 Catalog Number : AFO-L-SB

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOLX0 Catalog Number : AFO-LX

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOLXSB0 Catalog Number : AFO-LX-SB

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFOR0 Catalog Number : AFO-R

Device Description : Ankle/Foot Orthosis, size Regular

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFORE0 Catalog Number : AFO-RE

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFORESB0 Catalog Number : AFO-RE-SB

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

BMI - G088AFORL0 Catalog Number : AFO-RL

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

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