FDA.reportPublic FDA data

Optiheal Hydration Multi Purpose Dressing

Primary DI
05060247390642
Brand
Optiheal Hydration Multi Purpose Dressing
Company
Neo G USA Inc
Model
AW007
Catalog number
AW007
Device description
Hydration Multi Purpose Dressing
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
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060247390642PackageGS190In Commercial Distribution
05060247393070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060247390642050602473906425060247390642
05060247393070050602473930705060247393070

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). 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
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
01714196112452DermaRite Medical Wound Gel- Amorphous HydrogelSion Brands LLCNAE2026-06-01
00850060751738SkinPenBellus Medical, LLCNAE2026-05-20
00860015727336KegelStar Port IncNAE2026-04-27
10840330704936ProCureTwin Med, LLCNAE2026-04-22
10840330704943ProCureTwin Med, LLCNAE2026-04-22
10840330705803ProCureTwin Med, LLCNAE2026-04-22
10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
00858071004478Natural Shield Wound Dressing, 1oz brush onKericure Inc.NAE2025-10-06
00858071004553Natural Shield Wound Dressing, 1oz sprayKericure Inc.NAE2025-10-06
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
00197998326967Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
15056860000034Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000041Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000058Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
10197344110162MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-08-04
06974600043672KONLIDASuzhou Konlida Medical Supplies Co., Ltd.NAE2025-07-28
M689HHWSK02050Wound Seal KitSafeguard US Operating, LLCNAE2025-06-24
06971292003694AUVONShenzhen Yuwen E-Commerce Co., Ltd.NAE2025-06-19
06971292003700AUVONShenzhen Yuwen E-Commerce Co., Ltd.NAE2025-06-19
00810040134692SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00810040134708SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00361554005614GentellGentell, LLCNAE2025-02-14