FDA.reportPublic FDA data

Phoenix Surgical Wound Matrix Fenestrated

Primary DI
00852513007003
Brand
Phoenix Surgical Wound Matrix Fenestrated
Company
NANOFIBER SOLUTIONS, INC.
Model
FG-0051
Catalog number
FG-0051
Published
2023-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852513007003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852513007003008525130070038525130070030852513007003

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

Regulatory Flags#

DUNS number
830384223
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852513007058Rotium Bioresorbable WickFG-00072019-04-03
00852513007447RotiumFG-02202025-04-17
00852513007454RotiumFG-03252025-04-17
00852513007461RotiumFG-04302025-04-17
00852513007478RotiumFG-05252025-04-17
00852513007485RotiumFG-06302025-04-17
00852513007492RotiumFG-07252025-04-17
00852513007317Rotium Bioresorbable WickFG-00432022-10-18
00852513007393Phoenix Surgical Wound Matrix FenestratedFG-00532025-04-17
00852513007409Phoenix Surgical Wound Matrix FenestratedFG-00542025-04-17
00852513007416Phoenix Surgical Wound Matrix FenestratedFG-00552025-04-17
00852513007423Phoenix Surgical Wound Matrix FenestratedFG-00562025-04-17
00852513007430Phoenix Surgical Wound Matrix FenestratedFG-00572025-04-17
00852513007362ElectroFiber 3D MatrixFG-0061EF3D-10202024-11-14
00852513007379ElectroFiber 3D MatrixFG-0062EF3D-10102024-11-14
00852513007386ElectroFiber 3D MatrixFG-0063EF3D-05052024-11-14
00852513007355BIOCHARGEFG-2012BC-20122024-09-25
00852513007331Rotium RCO Bioresorbable WickFG-10232024-01-09
00852513007348Rotium RCO Bioresorbable WickFG-10432024-01-09
00852513007324Phoenix Surgical Wound Matrix FenestratedFG-0052FG-00522023-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10