ManaMed Inc EZIWSHLDR01

GUDID 00810113682532

ManaEZ Ice Wrap Shoulder is a quick fitting, universal, shoulder orthosis. This shoulder brace also includes an ice pack. Removable ice pack Lightweight, latex free breathable material Effortless application, universal size with hook and loop closure Designed for either left or right shoulder

MANAMED INC

Shoulder support/thermal therapy bandage
Primary Device ID00810113682532
NIH Device Record Key70e1e497-cbb1-44d7-afa8-cf7af80fa9d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameManaMed Inc
Version Model NumberManaEZ Ice Wrap Shoulder
Catalog NumberEZIWSHLDR01
Company DUNS084042331
Company NameMANAMED 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113682532 [Primary]

FDA Product Code

KYRBag, Ice

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-09
Device Publish Date2022-09-01

On-Brand Devices [ManaMed Inc]

00810113682488The PrevenTech is intended to be an easy to use sequential compression system, prescribed by a p
00810113682549ManaEZ Ice Wrap Back is a quick fitting, universal, back orthosis. This back brace also includes
00810113682532ManaEZ Ice Wrap Shoulder is a quick fitting, universal, shoulder orthosis. This shoulder brace a
00810113682525A back and thigh extension strap for devices within our ManaEZ Hip line
00810113682617This device is universal, this product does not exist. Cannot delete record
00810113682600ManaEZ Ice Wrist is a quick fitting, universal, wrist orthosis. This wrist brace also includes a
00810113682624The PlasmaFlow is intended to be an easy to use sequential compression system, prescribed by a p
00810113682648Replacement abduction pillow used to keep shoulder aligned with sling.
00810113682631Replacement abduction pillow with pockets for phone and water bottles used to keep shoulder alig
00810113682679ManaCold Platinum Hip Pad attachment is used to decrease pain, swelling, and muscle spasms after
00810113682662ManaCold Platinum Back Pad attachment is used to decrease pain, swelling, and muscle spasms afte
00810113682655ManaCold Platinum Ankle Pad attachment is used to decrease pain, swelling, and muscle spasms aft
00810113681092Reusable extra large size compression calf garment, increases venous blood flow to help prevent

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.