FDA.reportPublic FDA data

curea P1 heel

Primary DI
04260223630989
Brand
curea P1 heel
Company
curea medical GmbH
Model
curea P1 heel 8 x 12 inch
Catalog number
3000258445
Device description
curea P1 heel Superabsorbent Wound Dressing
Published
2026-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260223639302PackageGS15In Commercial Distribution
14260223639309PackageGS135In Commercial Distribution
04260223630989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260223639302042602236393024260223639302
1426022363930914260223639309
04260223630989042602236309894260223630989

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
341599537
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
04260223630224curea P1curea P1 3 x 3 inch30002584522026-09-27
04260223630231curea P1curea P1 4 x 4 inch30002584232026-09-27
04260223630248curea P1curea P1 4 x 8 inch30002584222026-09-27
04260223630255curea P1curea P1 8 x 8 inch30002584482026-09-27
04260223630262curea P1curea P1 4 x 12 inch30002584212026-09-27
04260223630279curea P1curea P1 8 x 12 inch30002584192026-09-27
04260223630286curea P1 draincurea P1 drain 5 x 5 inch30002584512026-09-27
04260223630347curea P2curea P2 4 x 4 inch30002584412026-09-27
04260223630378curea P2curea P2 4 x 8 inch30002584422026-09-27
04260223630408curea P2curea P2 8 x 8 inch30002584392026-09-27
04260223630422curea P2curea P2 8 x 12 inch30002584382026-09-27
04260223630651curea P1curea P1 6 x 6 inch30002584492026-09-27
04260223630668curea P2curea P2 6 x 6 inch30002584402026-09-27
04260223630736curea P1curea P1 16 x 24 inch30002584462026-09-27
04260223630880curea P1curea P1 8 x 16 inch30002584472026-09-27
04260223631184curea P1 DUO activecurea P1 DUO active 4 x 4 inch30002584202026-09-27
04260223631191curea P1 DUO activecurea P1 DUO active 4 x 8 inch30002584182026-09-27
04260223631207curea P1 DUO activecurea P1 DUO active 8 x 8 inch30002584172026-09-27
04260223631214curea P1 DUO activecurea P1 DUO active 8 x 12 inch30002584342026-09-27
04260223631368curea P1curea P1 4 x 6 inch30002584502026-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223630224curea P1curea medical GmbHNAC2026-09-27
04260223630231curea P1curea medical GmbHNAC2026-09-27
04260223630248curea P1curea medical GmbHNAC2026-09-27
04260223630255curea P1curea medical GmbHNAC2026-09-27
04260223630262curea P1curea medical GmbHNAC2026-09-27
04260223630279curea P1curea medical GmbHNAC2026-09-27
04260223630286curea P1 draincurea medical GmbHNAC2026-09-27
04260223630347curea P2curea medical GmbHNAC2026-09-27
04260223630378curea P2curea medical GmbHNAC2026-09-27
04260223630408curea P2curea medical GmbHNAC2026-09-27
04260223630422curea P2curea medical GmbHNAC2026-09-27
04260223630651curea P1curea medical GmbHNAC2026-09-27
04260223630668curea P2curea medical GmbHNAC2026-09-27
04260223630736curea P1curea medical GmbHNAC2026-09-27
04260223630880curea P1curea medical GmbHNAC2026-09-27
04260223631184curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631191curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631207curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631214curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631368curea P1curea medical GmbHNAC2026-09-27
04260223631672curea P2curea medical GmbHNAC2026-09-27
04260223631696curea P2curea medical GmbHNAC2026-09-27
04260223631757curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631771curea P2 activecurea medical GmbHNAC2026-09-27
04260223631795curea P2 activecurea medical GmbHNAC2026-09-27
04260223631849curea P2 activecurea medical GmbHNAC2026-09-27
04260223631931curea P1 easy bordercurea medical GmbHNAC2026-09-27
00749756401920DeRoyalDEROYAL INDUSTRIES, INC.NAC2026-09-18
00841277111286Novera SeamHarps USA, Inc.NAC2026-09-04
00197998326615Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26