Kentec ArmBoard 405ABV

GUDID 20817522010325

405 size armboard with velcro strap

KENTEC MEDICAL, INC.

Infant limb immobilizer, reusable
Primary Device ID20817522010325
NIH Device Record Key5660c44d-4b04-4729-9425-c6648bc06cfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameKentec ArmBoard
Version Model Number405ABV
Catalog Number405ABV
Company DUNS066175613
Company NameKENTEC MEDICAL, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110817522010328 [Primary]
GS120817522010325 [Package]
Contains: 10817522010328
Package: box [48 Units]
In Commercial Distribution
GS130817522010322 [Package]
Package: case [288 Units]
In Commercial Distribution

FDA Product Code

NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-24
Device Publish Date2021-12-16

On-Brand Devices [Kentec ArmBoard]

20817522010325405 size armboard with velcro strap
20817522010318405 size armboard
20817522010295404 size armboard with velcro strap
10817522010281404 size armboard
20817522010264403 size armboard with velcro strap
20817522010257403 size armboard

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