Maramed Orthopedic Systems PLS-FF-400L

GUDID 00810050250832

The ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are fabricated in a predorsiflexed position to provide superior dorsiflexion assist. Size = X-Large, Side = Left

BIOSCULPTOR CORPORATION

Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis
Primary Device ID00810050250832
NIH Device Record Key1a0f17d4-964a-4c7f-91fd-5743068b0d88
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaramed Orthopedic Systems
Version Model NumberPLS-FF-400L
Catalog NumberPLS-FF-400L
Company DUNS926813379
Company NameBIOSCULPTOR CORPORATION
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com
Phone305-823-8300
Emailinfo@maramed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050250832 [Primary]

FDA Product Code

OHIOrthosis, Foot Drop

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-07
Device Publish Date2023-11-29

On-Brand Devices [Maramed Orthopedic Systems]

00810050250849The ankle foot orthoses/drop foot splints provide a full foot section for additional support and
00810050250832The ankle foot orthoses/drop foot splints provide a full foot section for additional support and
00810050250825The ankle foot orthoses/drop foot splints provide a full foot section for additional support and
00810050250818The ankle foot orthoses/drop foot splints provide a full foot section for additional support and
00810050250801The ankle foot orthoses/drop foot splints provide a full foot section for additional support and
00810050250795The ankle foot orthoses/drop foot splints provide a full foot section for additional support and
00810050250788The ankle foot orthoses/drop foot splints provide a full foot section for additional support and
00810050250771The ankle foot orthoses/drop foot splints provide a full foot section for additional support and
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