FDA.reportPublic FDA data

Orchid

Primary DI
00198926007460
Brand
Orchid
Company
Quest USA Corp.
Model
OR2859-DT
Device description
Acne patch 24 pcs in a sheet, heart shape, purple color
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00198926007460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198926007460001989260074601989260074600198926007460

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079869689
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198926007453OrchidOR2858-DT2026-02-03
00198926007477OrchidOR2860-DT2026-02-03
00810146465553OrchidOR2759-DT2026-02-02
00810146461463OrchidBP27032024-03-01
00810146461470OrchidBP27042024-03-01
10198926000307BIOPURE BP2703-1PK2025-03-01
10198926000314BIOPURE BP2797-1PK2025-03-01
10198926000338BIOPURE BP2704-1PK2025-03-01
10198926000352BIOPURE BP2798-1PK2025-03-01
00198926004414BIOPURE BP2703-1PK2025-03-01
00198926004438BIOPURE BP2797-1PK2025-03-01
00198926004421BIOPURE BP2704-1PK2025-03-01
00198926004445BIOPURE BP2798-1PK2025-03-01
00810146467182NUMINU700012024-08-01
00810146468929NUMINU700002024-08-01
10810146461460OrchidBP27032024-03-01
10810146461477OrchidBP27042024-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
04260223630989curea P1 heelcurea 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
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00841277111286Novera SeamHarps USA, Inc.NAC2026-09-04