FDA.reportPublic FDA data

Atrauman Silicone st 7,5x10cm P10 C4

Primary DI
04052199255439
Brand
Atrauman Silicone st 7,5x10cm P10 C4
Company
PAUL HARTMANN AG
Model
499562 Atrauman Silicone st 7,5x10cm P10 C4
Device description
Atrauman Silicone st 7,5x10cm P10 C4
Published
2020-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052199255446PackageGS110In Commercial Distribution
04052199255453PackageGS14In Commercial Distribution
04052199255439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052199255446040521992554464052199255446
04052199255453040521992554534052199255453
04052199255439040521992554394052199255439

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Regulatory Flags#

DUNS number
315768788
Device count
1
Premarket exempt
true
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
04049500834919HydroTac transparent 5cmx7,5cm st P10685900 HydroTac transparent 5cmx7,5cm st P106859002020-09-01
04049500834940HydroTac transparent 10cmx10cm st P10685901 HydroTac transparent 10cmx10cm st P106859012020-09-01
04049500834971HydroTac transparent 10x20cm st P10 C6685902 HydroTac transparent 10x20cm st P10 C66859022020-09-01
04049500835008HydroTac transparent 20x20cm st P10685903 HydroTac transparent 20x20cm st P106859032020-09-01
04049500835039HydroTac transparent comf. 8x8cm st P10685920 HydroTac transparent comf. 8x8cm st P106859202020-09-01
04049500835091HydroTac transp. comf. 10x20cm st P10685922 HydroTac transp. comf. 10x20cm st P106859222020-09-01
04049500835121HydroTac transp. comf. 6,5x10cm st P10685923 HydroTac transp. comf. 6,5x10cm st P106859232020-09-01
04052199273501HydroTac transparent 5x7,5cm steril P10685905 HydroTac transparent 5x7,5cm steril P102020-09-01
04052199273563HydroTac transp. comfort 8x8cm st P10685925 HydroTac transp. comfort 8x8cm st P102020-09-01
04052199273600HydroTac transp. comf.12,5x12,5cm st P10685926 HydroTac transp. comf.12,5x12,5cm st P102020-09-01
04052199273648HydroTac transp. comf. 10x20cm st P10685927 HydroTac transp. comf. 10x20cm st P102020-09-01
04052199273686HydroTac transp. comf. 6,5x10cm st P10685928 HydroTac transp. comf. 6,5x10cm st P102020-09-01
04052199274201HydroTac transparent 10x10cm steril P10685906 HydroTac transparent 10x10cm steril P102020-09-01
04052199274249HydroTac transparent 10x20cm steril P10685907 HydroTac transparent 10x20cm steril P102020-09-01
04052199274287HydroTac transparent 20x20cm steril P10685908 HydroTac transparent 20x20cm steril P102020-09-01
04049500835060HydroTac transp.comf. 12,5x12,5cm st P10685921 HydroTac transp.comf. 12,5x12,5cm st P106859212020-09-01
04052199807188Zetuvit Plus413926 Zetuvit Plus Shapes Oval4139262026-09-28
04052199810157Foliodrape Protect Plus936022 Foliodrape Protect Plus One Drape Solution 9360222026-03-09
04052199810171Foliodrape Protect Plus936023 Foliodrape Protect Plus One Drape Solution 9360232026-03-09
04052199810195Foliodrape Protect Plus936024 One Drape Solution Knee drape with 1 stocki9360242026-03-09

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