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, Knee, External Brace (ITQ) (5) Splint, Hand, And Components (ILH) (5)

Premarket Exempt

Yes

Clear

BMI - G088HTALR0 Catalog Number : HTA-LR

Device Description : Resting Hand with Thumb Abductor orthosis, size: Large, side: Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTAPL0 Catalog Number : HTA-PL

Device Description : Resting Hand with Thumb Abductor orthosis, size: Petite, side: Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTAPR0 Catalog Number : HTA-PR

Device Description : Resting Hand with Thumb Abductor orthosis, size: Petite, side: Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTARL0 Catalog Number : HTA-RL

Device Description : Resting Hand with Thumb Abductor orthosis, size: Regular, side: Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTARR0 Catalog Number : HTA-RR

Device Description : Resting Hand with Thumb Abductor orthosis, size: Regular, side: Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088KCALL0 Catalog Number : KCA-LL

Device Description : Knee Corrective Orthosis with Air Bladder. Size Large/Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITQ

Prescription Use : No

Device Count : 1

BMI - G088KCALR0 Catalog Number : KCA-LR

Device Description : Knee Corrective Orthosis with Air Bladder. Size Large/Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITQ

Prescription Use : No

Device Count : 1

BMI - G088KCAML0 Catalog Number : KCA-ML

Device Description : Knee Corrective Orthosis with Air Bladder. Size Medium/Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITQ

Prescription Use : No

Device Count : 1

BMI - G088KCAMR0 Catalog Number : KCA-MR

Device Description : Knee Corrective Orthosis with Air Bladder. Size Medium/Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITQ

Prescription Use : No

Device Count : 1

BMI - G088KCAPL0 Catalog Number : KCA-PL

Device Description : Knee Corrective Orthosis with Air Bladder. Size Petite/Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ITQ

Prescription Use : No

Device Count : 1

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