Optiheal Silicone Postsurgical Dressing

Primary DI
05060247390628
Brand
Optiheal Silicone Postsurgical Dressing
Company
Neo G USA Inc
Model
AW002
Catalog number
AW002
Device description
Silicone Postsurgical Dressing 8x4in / 20x10cm
Published
2021-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
05060247390628PackageGS140In Commercial Distribution
05060247398020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060247390628050602473906285060247390628
05060247398020050602473980205060247398020

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
05060247390604Optiheal Silicone Foam Absorbent DressingAW001AW0012021-01-19

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