BMI AFO-EL-SB

GUDID G088AFOELSB0

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

Blake Manufacturing, Inc.

Ankle/foot orthosis
Primary Device IDG088AFOELSB0
NIH Device Record Key9772bc1e-4f56-4554-bbe3-fef531b5440a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBMI
Version Model NumberAFO-EL-SB
Catalog NumberAFO-EL-SB
Company DUNS103449711
Company NameBlake Manufacturing, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG088AFOELSB0 [Primary]

FDA Product Code

ITWJoint, Ankle, External Brace

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-23
Device Publish Date2021-09-15

On-Brand Devices [BMI]

G088AFOR0Ankle/Foot Orthosis, size Regular
G088AFOXE0Ankle/Foot Orthosis, size Extra Large-Edema
G088AFOX0Ankle/Foot Orthosis, size Extra Large
G088AFORL0Ankle/Foot Orthosis, size Regular-Large
G088AFOLX0Ankle/Foot Orthosis, size Large-Extra Large
G088AFOL0Ankle/Foot Orthosis, size Large
G088AFOE0Ankle/Foot Orthosis, size Edema
G088AFOXR0Ankle/Foot Orthosis, size Extra Large/Regular
G088AFOLR0Ankle/Foot Orthosis, size Large/Regular
G088AFOXSB0Ankle/Foot Orthosis, size Extra Large (Shortback version)
G088AFOXRSB0Ankle/Foot Orthosis, size Extra Large/Regular (Shortback version)
G088AFOXLSB0Ankle/Foot Orthosis, size Extra Large/Large (Shortback version)
G088AFOXL0Ankle/Foot Orthosis, size Extra Large/Large
G088AFOXESB0Ankle/Foot Orthosis, size Extra Large/Edema (Shortback version)
G088AFORXSB0Ankle/Foot Orthosis, size Regular/Extra Large (Shortback version)
G088AFORX0Ankle/Foot Orthosis, size Regular/Extra Large
G088AFORSB0Ankle/Foot Orthosis, size Regular (Shortback version)
G088AFORLSB0Ankle/Foot Orthosis, size Regular/Large (Shortback version)
G088AFORESB0Ankle/Foot Orthosis, size Regular/Edema (Shortback version)
G088AFORE0Ankle/Foot Orthosis, size Regular/Edema
G088AFOLXSB0Ankle/Foot Orthosis, size Large/Extra Large (Shortback version)
G088AFOLSB0Ankle/Foot Orthosis, size Large (Shortback version)
G088AFOLRSB0Ankle/Foot Orthosis, size Large/Regular (Shortback version)
G088AFOLESB0Ankle/Foot Orthosis, size Large/Edema (Shortback version)
G088AFOLE0Ankle/Foot Orthosis, size Large/Edema
G088AFOEXSB0Ankle/Foot Orthosis, size Edema/Extra Large (Shortback version)
G088AFOEX0Ankle/Foot Orthosis, size Edema/Extra Large
G088AFOESB0Ankle/Foot Orthosis, size Edema (Shortback version)
G088AFOERSB0Ankle/Foot Orthosis, size Edema/Regular (Shortback version)
G088AFOER0Ankle/Foot Orthosis, size Edema/Regular
G088AFOELSB0Ankle/Foot Orthosis, size Edema/Large (Shortback version)
G088AFOEL0Ankle/Foot Orthosis, size Edema/Large
G088HRERR0BMI Resting Hand, size Regular/Right
G088HREPR0Resting Hand, size Petite-Right
G088HREPL0Resting Hand, size Petite-Left
G088HRELL0Resting Hand, size Large-Left
G088MSCPGR0Palm Guard, Right sided
G088MSCPGL0Palm Guard - Left sided
G088MSCAPDS0Abductor Pillow, Double-straps
G088MSCAP0Abductor Pillow
G088HRERL0Resting Hand, size Regular-Left
G088HRELR0Resting Hand, size Large-Right
G088KNEX0Knee, Neoprene Orthosis, size Extra-Large
G088KNES0Knee, Neoprene Orthosis, size Small
G088KNEM0Knee, Neoprene Orthosis, size Medium
G088KNEL0Knee, Neoprene Orthosis, size Large
G088KCOXXR0Knee Corrective Orthosis, size XX-Large/Right
G088KCOXXL0Knee Corrective Orthosis, size XX-Large/Left
G088KCOXR0Knee Corrective Orthosis, size Extra-Large/Right
G088KCOXL0Knee Corrective Orthosis, size Extra Large-Left

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