FDA.reportPublic FDA data

StingGone Protective Barrier Wipes, Alcohol-Free

Primary DI
00616784150321
Brand
StingGone Protective Barrier Wipes, Alcohol-Free
Company
Dynarex Corporation
Model
1503
Device description
Ingredients: Water, Propylene Glycol, PVP, Tetrasodium EDTA, Polyaminopropyl (Biguanide), Methylchloroisothiazolinone, Methylisothiazolinone (may contain Triethanolamine, Citric Acid)
Published
2025-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NECBandage, Liquid, Skin Protectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NECBandage, Liquid, Skin ProtectantGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784150338PackageGS120In Commercial Distribution
00616784150321PrimaryGS10
00810180842280Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784150338006167841503386167841503380616784150338
00616784150321006167841503216167841503210616784150321
00810180842280008101808422808101808422800810180842280

GMDN Terms#

Term, Definition table
TermDefinition
Skin adhesive protective materialA liquid preparation designed to be applied evenly over intact skin to form a synthetic polymer film, prior to application of an adhesive strip/bandage, to protect the skin during subsequent removal of the adhesive strip/bandage. It may be presented as a wipe/swab. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
008124539
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117309210Resp-O2 Suction Tubing Combo Pack, Non-Sterile321002021-04-22
00840117309234Resp-O2 Suction Connecting Tubing, Non-Conductive321032021-04-22
00840117309258Resp-O2 Suction Connecting Tubing, Non-Conductive321042021-04-22
00840117309272Resp-O2 Suction Connecting Tubing, Non-Conductive321062021-04-22
00840117309296Resp-O2 Suction Connecting Tubing, Non-Conductive321072021-04-22
00840117309371Resp-O2 Suction Connecting Tubing, Non-Conductive321112021-04-22
00840117309395Resp-O2 Suction Connecting Tubing, Non-Conductive321122021-04-22
00840117313651Resp-O2 Suction Connecting Tubing, Non-Conductive321052021-04-22
00840117309418Resp-O2 Yankauer Suction Handle, Bulb Tip, Vented,321202022-05-10
00840117309432Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321212022-05-10
00840117309456Resp-O2 Yankauer Suction Handle, Straight Tip, Vented321222022-05-10
00840117309319Resp-O2 Suction Connecting Tubing, Non-Conductive321082022-05-09
00840117309326Resp-O2 Suction Connecting Tubing, Non-Conductive321092022-05-09
00840117309357Resp-O2 Suction Connecting Tubing, Non-Conductive321102022-05-09
00840117309494Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321262022-05-09
00840117309470Resp-O2 Yankauer Suction Handle, Straight Tip, Non-Vented321232022-04-21
00840117313675Resp-O2 Yankauer Suction Handles, Bulb Tip, Non-Vented321252022-04-21
00840117313699Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321272022-04-21
00840117313712Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321282022-04-21
00840117321748Resp-O2 Suction Connecting Tubing, Non-Sterile321012022-04-21

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