FDA.reportPublic FDA data

Optiheal Ultra Thin Absorbent Film

Primary DI
05060247394060
Brand
Optiheal Ultra Thin Absorbent Film
Company
Neo G USA Inc
Model
AW006
Catalog number
AW006
Device description
Ultra Thin Absorbent Film 4x4in / 10x10cm
Published
2021-01-19
Public version status
Update
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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060247394060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060247394060050602473940605060247394060

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, 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
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
00819333029028Optiheal Silicone Postsurgical DressingAW002AAW0022021-08-23
00819333029035Optiheal Silicone Multi Purpose DressingAW003AAW0032021-08-23
00819333029066Optiheal Ultra Thin Absorbent FilmAW006AAW0062021-08-23
00819333029073Optiheal Hydration Multi Purpose DressingAW007AAW0072021-08-23
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

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Primary DI, Brand, Company table
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04719873697823NACARILEX MEDICAL, INC.NAD2026-08-26
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040640351931573M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
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05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
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