FDA.reportPublic FDA data

Atrauman Ag

Primary DI
04052199732442
Brand
Atrauman Ag
Company
PAUL HARTMANN AG
Model
499607 Atrauman Ag USA st 10x10cm, P10
Catalog number
499607
Device description
Atrauman Ag USA st 10x10cm, P10
Published
2025-03-19
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242758000Atrauman® AgHartmann USA, Inc.2024-12-09FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052199732442PackageGS110In Commercial Distribution
04052199732459PackageGS112In Commercial Distribution
04052199732435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052199732442040521997324424052199732442
04052199732459040521997324594052199732459
04052199732435040521997324354052199732435

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

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
true
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
false
Sterilization required before use
false

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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Primary DI, Brand, Company table
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05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
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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
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08