PFAB SMALL PFAB-S

GUDID 00856525007365

Silicone Foam Dressing with Air Bolster

SUN SCIENTIFIC, INC.

Synthetic nanofiber barrier dressing
Primary Device ID00856525007365
NIH Device Record Key4b398bc5-b820-4564-bebb-267fc78161e4
Commercial Distribution Discontinuation2025-01-01
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFAB SMALL
Version Model NumberPFAB-S
Catalog NumberPFAB-S
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-Counterfalse

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
Phone9144795108
Emailaalward@sun-scientific.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856525007365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHWDressing, Compression

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-10
Device Publish Date2021-04-30

Devices Manufactured by SUN SCIENTIFIC, INC.

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00850051939572 - 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
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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