FDA.reportPublic FDA data

SV BOLSTER Medium

Primary DI
00856525007136
Brand
SV BOLSTER Medium
Company
SUN SCIENTIFIC, INC.
Model
SP2355
Catalog number
SP2355
Device description
SAPHENOUS VEIN COMPRESSION FOAM DRESSING WITH AIR BOLSTER MEDIUM
Published
2022-04-26
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
MHWDressing, Compression
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00856525007136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856525007136008565250071368565250071360856525007136

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

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
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
00856525007396PFAB LargePFAB-LPFAB-L2021-04-30
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
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06979191881979OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191882280NanacareWAL-MART STORES, INC.NAC2026-07-31
06974692681561GUANGYIJiangsu Guangyi Medical Dressing Co.,LTD.NAC2026-07-22
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