BMI AFO-LX-SB

GUDID G088AFOLXSB0

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

Blake Manufacturing, Inc.

Ankle/foot orthosis

• Primary Device ID: G088AFOLXSB0
• NIH Device Record Key: 76542160-2c9d-48b8-a774-ca7ca7c5d6a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BMI
• Version Model Number: AFO-LX-SB
• Catalog Number: AFO-LX-SB
• Company DUNS: 103449711
• Company Name: Blake Manufacturing, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G088AFOLXSB0 [Primary]

FDA Product Code

• ITW: Joint, Ankle, External Brace

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-23
• Device Publish Date: 2021-09-15

On-Brand Devices [BMI]

• G088AFOR0: Ankle/Foot Orthosis, size Regular
• G088AFOXE0: Ankle/Foot Orthosis, size Extra Large-Edema
• G088AFOX0: Ankle/Foot Orthosis, size Extra Large
• G088AFORL0: Ankle/Foot Orthosis, size Regular-Large
• G088AFOLX0: Ankle/Foot Orthosis, size Large-Extra Large
• G088AFOL0: Ankle/Foot Orthosis, size Large
• G088AFOE0: Ankle/Foot Orthosis, size Edema
• G088AFOXR0: Ankle/Foot Orthosis, size Extra Large/Regular
• G088AFOLR0: Ankle/Foot Orthosis, size Large/Regular
• G088AFOXSB0: Ankle/Foot Orthosis, size Extra Large (Shortback version)
• G088AFOXRSB0: Ankle/Foot Orthosis, size Extra Large/Regular (Shortback version)
• G088AFOXLSB0: Ankle/Foot Orthosis, size Extra Large/Large (Shortback version)
• G088AFOXL0: Ankle/Foot Orthosis, size Extra Large/Large
• G088AFOXESB0: Ankle/Foot Orthosis, size Extra Large/Edema (Shortback version)
• G088AFORXSB0: Ankle/Foot Orthosis, size Regular/Extra Large (Shortback version)
• G088AFORX0: Ankle/Foot Orthosis, size Regular/Extra Large
• G088AFORSB0: Ankle/Foot Orthosis, size Regular (Shortback version)
• G088AFORLSB0: Ankle/Foot Orthosis, size Regular/Large (Shortback version)
• G088AFORESB0: Ankle/Foot Orthosis, size Regular/Edema (Shortback version)
• G088AFORE0: Ankle/Foot Orthosis, size Regular/Edema
• G088AFOLXSB0: Ankle/Foot Orthosis, size Large/Extra Large (Shortback version)
• G088AFOLSB0: Ankle/Foot Orthosis, size Large (Shortback version)
• G088AFOLRSB0: Ankle/Foot Orthosis, size Large/Regular (Shortback version)
• G088AFOLESB0: Ankle/Foot Orthosis, size Large/Edema (Shortback version)
• G088AFOLE0: Ankle/Foot Orthosis, size Large/Edema
• G088AFOEXSB0: Ankle/Foot Orthosis, size Edema/Extra Large (Shortback version)
• G088AFOEX0: Ankle/Foot Orthosis, size Edema/Extra Large
• G088AFOESB0: Ankle/Foot Orthosis, size Edema (Shortback version)
• G088AFOERSB0: Ankle/Foot Orthosis, size Edema/Regular (Shortback version)
• G088AFOER0: Ankle/Foot Orthosis, size Edema/Regular
• G088AFOELSB0: Ankle/Foot Orthosis, size Edema/Large (Shortback version)
• G088AFOEL0: Ankle/Foot Orthosis, size Edema/Large
• G088HRERR0: BMI Resting Hand, size Regular/Right
• G088HREPR0: Resting Hand, size Petite-Right
• G088HREPL0: Resting Hand, size Petite-Left
• G088HRELL0: Resting Hand, size Large-Left
• G088MSCPGR0: Palm Guard, Right sided
• G088MSCPGL0: Palm Guard - Left sided
• G088MSCAPDS0: Abductor Pillow, Double-straps
• G088MSCAP0: Abductor Pillow
• G088HRERL0: Resting Hand, size Regular-Left
• G088HRELR0: Resting Hand, size Large-Right
• G088KNEX0: Knee, Neoprene Orthosis, size Extra-Large
• G088KNES0: Knee, Neoprene Orthosis, size Small
• G088KNEM0: Knee, Neoprene Orthosis, size Medium
• G088KNEL0: Knee, Neoprene Orthosis, size Large
• G088KCOXXR0: Knee Corrective Orthosis, size XX-Large/Right
• G088KCOXXL0: Knee Corrective Orthosis, size XX-Large/Left
• G088KCOXR0: Knee Corrective Orthosis, size Extra-Large/Right
• G088KCOXL0: Knee Corrective Orthosis, size Extra Large-Left