FDA.reportPublic FDA data

Orchid

Primary DI
00198926007453
Brand
Orchid
Company
Quest USA Corp.
Model
OR2858-DT
Device description
Acne patch 24 pcs in a sheet, butterfly shape
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
00198926007453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198926007453001989260074531989260074530198926007453

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
00198926007460OrchidOR2859-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

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Primary DI, Brand, Company table
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00197998152283Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152313Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
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00197998152375Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
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00197998305955Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305986Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
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