FDA.reportPublic FDA data

PFAB Large

Primary DI
00856525007396
Brand
PFAB Large
Company
SUN SCIENTIFIC, INC.
Model
PFAB-L
Catalog number
PFAB-L
Device description
Silicone Foam Dressing with Air Bolster
Published
2021-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGPDressing, Wound And Burn, Occlusive
MHWDressing, Compression
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGPDressing, Wound And Burn, OcclusiveUnknownU
MHWDressing, CompressionGeneral Hospital1
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070457000SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFABSun Scientific, LLC2007-05-16MHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856525007396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856525007396008565250073968565250073960856525007396

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic nanofiber barrier dressingA sterile covering made of porous, non-woven, synthetic nanofiber material intended to provide protection and/or promote healing of acute and chronic skin wounds. It is a thin, synthetic polymer (e.g., polycaprolactone) fabric material intended to adhere to the wound (without adhesive) to form a barrier against contamination (e.g., from dirt, water, bacteria) while allowing air to contact the wound; it may be semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) and provides minimal wound exudate absorbency. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9144795108aalward@sun-scientific.com

Regulatory Flags#

DUNS number
609397224
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856525007082SunGauze, Gauze Dialysis Needle Dressing 60mm x 74mmPA1050-00SGP2021-07-21
00856525007068SunWrap Forearm U Bladder RightSW6280-00SW-FAUBR2021-05-10
00856525007235Rav Positioner Small2030SRAVP1000S2022-01-12
00856525007730Rav Positioner2030RAVP10002019-12-20
00856525007860Hip Off-Loader Assy, Medium FP7265 FP72652022-11-18
00856525007877Heel Off-Loader Assy, Medium HP7265 HP72652022-11-18
00856525007884SACRAL Off-Loader Assy, Medium SP7265 SP72652022-11-18
00856525007136SV BOLSTER MediumSP2355 SP23552022-04-26
00856525007143SV BOLSTER LARGESP2555 SP25552022-04-26
00856525007365PFAB SMALLPFAB-SPFAB-S2021-04-30
00856525007372PFAB MediumPFAB-MPFAB-M2021-04-30
00856525007389PFAB Medium CrescentPFAB-MCPFAB-MC2021-04-30
00850051939565AeroWrap™ Full LegFL-FL-SL-L-SF-SFL-FL-SL-L-SF-S2024-12-05
00850051939572AeroWrap™ Full LegFL-FL-SL-L-SF-MFL-FL-SL-L-SF-M2024-12-05
00850051939589AeroWrap™ Full LegFL-FL-SL-L-SF-LFL-FL-SL-L-SF-L2024-12-05
00850051939596AeroWrap™ Full LegFL-FL-SL-L-MF-SFL-FL-SL-L-MF-S2024-12-05
00850051939602AeroWrap™ Full LegFL-FL-SL-L-MF-MFL-FL-SL-L-MF-M2024-12-05
00850051939619AeroWrap™ Full LegFL-FL-SL-L-MF-LFL-FL-SL-L-MF-L2024-12-05
00850051939626AeroWrap™ Full LegFL-FL-SL-L-LF-SFL-FL-SL-L-LF-S2024-12-05
00850051939640AeroWrap™ Full LegFL-FL-SL-L-LF-LFL-FL-SL-L-LF-L2024-12-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
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09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
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09551031940168DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
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09551031940182DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
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09551031940229DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22