SunWrap Forearm U Bladder Left SW-FAUB

GUDID 00856525007075

Gradient compression arm sleeve with the see through bladder in the shape of a U

SUN SCIENTIFIC, INC.

Compression/pressure tubular garment
Primary Device ID00856525007075
NIH Device Record Key0a445e59-272c-4c9f-b050-aeaabdd05110
Commercial Distribution Discontinuation2026-05-18
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunWrap Forearm U Bladder Left
Version Model NumberSW6280-01
Catalog NumberSW-FAUB
Company DUNS609397224
Company NameSUN SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856525007075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHWDressing, Compression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-18
Device Publish Date2021-05-10

Devices Manufactured by SUN SCIENTIFIC, INC.

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00850051939589 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939596 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939602 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939619 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939626 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939640 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k

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