FDA.reportPublic FDA data

Optiheal Silicone Postsurgical Dressing

Primary DI
00819333029028
Brand
Optiheal Silicone Postsurgical Dressing
Company
Neo G USA Inc
Model
AW002A
Catalog number
AW002
Device description
Silicone Postsurgical Dressing 8x4in / 20x10cm
Published
2021-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00819333029028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819333029028008193330290288193330290280819333029028

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079218498
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060247395050Optiheal Silicone Wound Recovery StripsAW005AW0052021-01-19
00819333029059Optiheal Silicone Wound Recovery StripsAW005AAW0052021-08-23
05060247396040Optiheal Soft Silicone TapeAW004AW0042021-01-19
00819333029042Optiheal Soft Silicone TapeAW004AAW0042021-08-23
00819333029011Optiheal Silicone Foam Absorbent DressingAW001AAW0012021-08-23
00819333029035Optiheal Silicone Multi Purpose DressingAW003AAW0032021-08-23
00819333029066Optiheal Ultra Thin Absorbent FilmAW006AAW0062021-08-23
00819333029073Optiheal Hydration Multi Purpose DressingAW007AAW0072021-08-23
05060247394060Optiheal Ultra Thin Absorbent FilmAW006AW0062021-01-19
05060247393070Optiheal Hydration Multi Purpose DressingAW007AW0072021-01-19
05060247397030Optiheal Silicone Multi Purpose DressingAW003AW0032021-01-19
05060247398020Optiheal Silicone Postsurgical DressingAW002AW0022021-01-19
05060247399010Optiheal Silicone Foam Absorbent DressingAW001AW0012021-01-19
05060247390642Optiheal Hydration Multi Purpose DressingAW007AW0072021-01-19
05060247390659Optiheal Silicone Wound Recovery StripsAW005AW0052021-01-19
05060247390635Optiheal Soft Silicone TapeAW004AW0042021-01-19
05060247390611Optiheal Silicone Multi Purpose DressingAW003AW0032021-01-19
05060247390628Optiheal Silicone Postsurgical DressingAW002AW0022021-01-19
05060247390604Optiheal Silicone Foam Absorbent DressingAW001AW0012021-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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04260223630736curea P1curea medical GmbHNAC2026-09-27
04260223630880curea P1curea medical GmbHNAC2026-09-27
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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
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00749756401920DeRoyalDEROYAL INDUSTRIES, INC.NAC2026-09-18
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