FDA.reportPublic FDA data

Optiheal Soft Silicone Tape

Primary DI
05060247396040
Brand
Optiheal Soft Silicone Tape
Company
Neo G USA Inc
Model
AW004
Catalog number
AW004
Device description
Soft Silicone Tape 25m
Published
2021-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060247390635PackageGS1125In Commercial Distribution
05060247396040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060247390635050602473906355060247390635
05060247396040050602473960405060247396040

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, siliconeA long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device.

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
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
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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00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586487Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07