FDA.reportPublic FDA data

PROXIMEL AG SILICONE DRESSING 3x3 10/BX

Primary DI
10612553023480
Brand
PROXIMEL AG SILICONE DRESSING 3x3 10/BX
Company
HARTMANN USA, INC.
Model
15100000
Device description
PROXIMEL AG SILICONE DRESSING 3x3 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
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.

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
10612553018073Sorbalgon Ag st 2g/30cm P59996092020-09-01
10612553018080Sorbalgon Ag st 15x15cm P59996102020-09-01
10612553018103Sorbalgon Ag st 5x5cm P109996122020-09-01
10612553023497PROXIMEL AG SILICONE DRESSING 4x4 10/BX152000002020-09-01
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
30612553024290COLACTIVE PLUS 7x7 10/BX103500002020-09-01
00612553000002CollaSorb 1g Powder9060039060032024-03-20
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
10612553015409STERILUX GZ SPONGE ST 2X2 8PLY 3000/CS568800002020-09-01
10612553015430STERILUX GZ SPONGE ST 4X4 12PLY 1200/CS569100002020-09-01
20612553015642ECONOLUX GZ NS 2X2 8PLY 5000/CS 14,5tex157000002020-09-01
20612553015666ECONOLUX GZ NS 4X4 8PLY 14,5tex 4000/CS4168162020-09-01
20612553015673ECONOLUX GZ NS 4X4 12PLY 2000/CS 14,5tex4168172020-09-01

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