FDA.reportPublic FDA data

PROXIMEL AG SILICONE DRESSING 4x4 10/BX

Primary DI
10612553023497
Brand
PROXIMEL AG SILICONE DRESSING 4x4 10/BX
Company
HARTMANN USA, INC.
Model
15200000
Device description
PROXIMEL AG SILICONE DRESSING 4x4 10/BX
Published
2020-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
20612553023494PackageGS110In Commercial Distribution
30612553023491PackageGS16In Commercial Distribution
10612553023497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061255302349420612553023494
3061255302349130612553023491
1061255302349710612553023497

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Regulatory Flags#

DUNS number
010137511
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
00612553000163VERIS906010 0.6X0.6 sheet 15/BX9060102026-10-01
00612553000170VERIS906011 1X1 sheet 15/BX9060112026-10-01
00612553000187VERIS906012 2X2 sheet 15/BX9060122026-10-01
00612553000194VERIS906013 0.3X8/3 strip 15/BX9060132026-10-01
30612553024290COLACTIVE PLUS 7x7 10/BX103500002020-09-01
04052199578729ColActive Plus Powder Ag Wound Filler101600022021-08-27
04052199578750ColActive Plus Powder Wound Filler101600012021-08-27
30612553024276ColActive Plus 2x2101600002020-09-01
30612553024283ColActive Plus 4x4101800002020-09-01
30612553024306ColActive Plus AG 2x2 600/cs103300002020-09-01
30612553024313ColActive Plus AG 4x4 300/cs103400002020-09-01
30612553024320COLACTIVE PLUS AG 7x7 10/BX103200002020-09-01
10612553018073Sorbalgon Ag st 2g/30cm P59996092020-09-01
10612553018080Sorbalgon Ag st 15x15cm P59996102020-09-01
10612553018103Sorbalgon Ag st 5x5cm P109996122020-09-01
10612553023480PROXIMEL AG SILICONE DRESSING 3x3 10/BX151000002020-09-01
10612553023503PROXIMEL AG SILICONE DRESSING 6x6 5/BX153000002020-09-01
10612553023510PROXIMEL AG SILICONE DRESSING 4x12 5/BX154000002020-09-01
10612553023527PROXIMEL AG DRESSING SM SACRAL 5/BX155000002020-09-01
10612553018097Sorbalgon Ag st 10x10cm P109996112020-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10080196299850MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-10-22
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
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05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08