FDA.reportPublic FDA data

PROXIMEL AG SILICONE DRESSING 3x3 10/BX

Primary DI
20612553023487
Brand
PROXIMEL AG SILICONE DRESSING 3x3 10/BX
Company
PAUL HARTMANN AG
Model
15100000
Device description
PROXIMEL AG SILICONE DRESSING 3x3 10/BX
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20612553023487PackageGS110In Commercial Distribution
30612553023484PackageGS16In Commercial Distribution
10612553023480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061255302348720612553023487
3061255302348430612553023484
1061255302348010612553023480

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315768788
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052199810164Foliodrape Protect Plus936022 Foliodrape Protect Plus One Drape Solution 9360222026-03-09
04052199810188Foliodrape Protect Plus936023 Foliodrape Protect Plus One Drape Solution 9360232026-03-09
04052199810201Foliodrape Protect Plus936024 One Drape Solution Knee drape with 1 stocki9360242026-03-09
04052199777382Zetuvit Plus413600 Zetuvit Plus Shapes Oval4136002026-01-20
04052199777412Zetuvit Plus413601 Zetuvit Plus Shapes Heart Multisite P10 C64136012026-01-20
04052199777436Zetuvit Plus413602 Zetuvit Plus Shapes Multisite P10 C64136022026-01-20
04052199708935Zetuvit Plus413729 Zetuvit Plus 6 x 6 cm P104137292024-12-10
04052199708959Zetuvit Plus413739 Zetuvit Plus 20 x 60 cm P104137392024-12-10
04052199732404Atrauman Ag499606 Atrauman Ag USA st 5x5cm, P10499606 2025-03-19
04052199732442Atrauman Ag499607 Atrauman Ag USA st 10x10cm, P104996072025-03-19
04052199732473Atrauman Ag499608 Atrauman Ag USA st 10x20cm, P104996082025-03-19
20612553013440AC TAPE PLUS 2X5 72/CS64210000 AC TAPE PLUS 2X5 72/CS642100002020-09-01
04052199571331Hydrofilm 6x7cm sterile New P1009700012023-05-17
04052199571393Hydrofilm 6x7cm sterile P109700002023-05-17
04052199571423Hydrofilm 15x20cm sterile P509700072023-05-17
04052199571461Hydrofilm 20x30cm sterile P109700102023-05-17
04052199571508Hydrofilm 10x15cm sterile P509700052023-05-17
04052199571546Hydrofilm 10x12,5cm sterile P1009700032023-05-17
04052199571577Hydrofilm 10x12,5cm sterile P109700022023-05-17
04052199571607Hydrofilm 10x15cm sterile P109700042023-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00365197409105A+D Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.FRO2026-05-25
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10885632434266HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468490HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468506HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468513HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468520HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509032HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509049HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509056HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509063HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632510199HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
06977727072211Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072228Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072235Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072242Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072419SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072426SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072433SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072440SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
00050428339770CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-03-20
04719883980090Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980311Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980342Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980359Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980366Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980373Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980380Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980397Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
05060996770023AcutarexAlliance Healing Technologies, LLCFRO2026-03-13