FlexBoard Wrist Support 140-0400-00

GUDID 20815614020269

The FlexBoard Model 4400 is an adjustable wrist support device that extends the patient's wrist at a desired angle.

SEMLER TECHNOLOGIES, INC.

Wrist immobilizer, single-use
Primary Device ID20815614020269
NIH Device Record Keya179817a-95d2-4520-bd03-3c0059c384db
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexBoard Wrist Support
Version Model Number4400
Catalog Number140-0400-00
Company DUNS042075700
Company NameSEMLER TECHNOLOGIES, 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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS110815614020262 [Primary]
GS120815614020269 [Package]
Contains: 10815614020262
Package: Case [40 Units]
In Commercial Distribution

FDA Product Code

FMQRestraint, Protective

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-25
Device Publish Date2022-11-17

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