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) (10)

Premarket Exempt

Yes

Clear

BMI - G088HSGRR0 Catalog Number : HSG-RR

Device Description : Slim Grip Hand orthosis, size: Regular, side: Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HSOFIRMU0 Catalog Number : HSO-FIRM-U

Device Description : Short opponens with dense foam orthotic, size: Universal, side: Universal

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HSOU0 Catalog Number : HSO-U

Device Description : Short Opponens orthotic, size: Universal, side: Universal

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTAKHLL0 Catalog Number : HTA-KH-LL

Device Description : Resting Hand with Thumb Abductor and Keyhole Strap orthosis. Size: Large, Side: Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTAKHLR0 Catalog Number : HTA-KH-LR

Device Description : Resting Hand with Thumb Abductor and Keyhole Strap orthosis. Size: Large, Side: Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTAKHPL0 Catalog Number : HTA-KH-PL

Device Description : Resting Hand with Thumb Abductor and Keyhole Strap orthosis. Size: Petite, Side: Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTAKHPR0 Catalog Number : HTA-KH-PR

Device Description : Resting Hand with Thumb Abductor and Keyhole Strap orthosis. Size: Petite, Side: Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTAKHRL0 Catalog Number : HTA-KH-RL

Device Description : Resting Hand with Thumb Abductor and Keyhole Strap orthosis. Size: Regular, Side: Left

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTAKHRR0 Catalog Number : HTA-KH-RR

Device Description : Resting Hand with Thumb Abductor and Keyhole Strap orthosis. Size: Regular, Side: Right

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

BMI - G088HTALL0 Catalog Number : HTA-LL

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

Device Class : 1

Duns Number: 103449711

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : No

Device Count : 1

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