FDA.report

REMOVE Wipes

Primary DI
00040565115665
Brand
REMOVE Wipes
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
403100
Catalog number
403100
Device description
Universal Adhesive Remover Wipe
Published
2020-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KOXSolvent, Adhesive Tape

Product Code Classifications

CodeDeviceSpecialtyClass
KOXSolvent, Adhesive TapeGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00040565115665PackageGS150In Commercial Distribution
30040565115666PackageGS120In Commercial Distribution
00040565111810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00040565115665000405651156650405651156650040565115665
3004056511566630040565115666
00040565111810000405651118100405651118100040565111810

GMDN Terms

TermDefinition
Patient medical adhesive removerA liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
216344051
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DIBrandModelCatalogPublished
05000223503956LEAF66807739668077392026-03-03
05000223503994LEAF66807745668077452026-03-01
00040565117706COVRSITE5971400059714000 / 597141002026-01-19
00040565117744COVRSITE5971430059714300 / 597144002026-01-19
00040565120256COVRSITE59715000597150002026-01-19
00040565120270COVRSITE59715100597151002026-01-19
00500223504335NOVIX66027708660277082026-01-13
05000223502713No Sting Skin Prep66807691668076912025-11-26
05000223499389RENASYS66803107668031072025-09-23
05000223499396RENASYS66803106668031062025-09-23
05000223499402RENASYS66803105668031052025-09-23
05000223504267RENASYS66807737668077372025-09-23
05000223504274RENASYS66807736668077362025-09-23
05000223504281RENASYS66807735668077352025-09-23
05000223501686ALLEVYN™ Ag+66027663660276632025-08-12
05000223501693ALLEVYN™ Ag+66027664660276642025-08-12
05000223501709ALLEVYN™ Ag+66027665660276652025-08-12
05000223501808ALLEVYN™ Ag+66027669660276692025-08-12
05000223501815ALLEVYN™ Ag+66027670660276702025-08-12
05000223503178ALLEVYN COMPLETE CARE66807697668076972025-07-30

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50749756877973DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02
50749756877980DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02
05708932500951BravaColoplast A/SKOX2022-12-02
05708932500357BravaColoplast A/SKOX2022-12-02
10610075068118Securi-THOLLISTER INCORPORATEDKOX2022-12-01
00840269506635LPLa Pointique International, Ltd.KOX2022-12-01
00840269506642LPLa Pointique International, Ltd.KOX2022-12-01
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00840269506673LPLa Pointique International, Ltd.KOX2022-12-01
00840269530173MaxtapingLa Pointique International, Ltd.KOX2022-12-01
00840269531194MaxtapingLa Pointique International, Ltd.KOX2022-12-01
00840269531200MaxtapingLa Pointique International, Ltd.KOX2022-12-01
00840269531842LPLa Pointique International, Ltd.KOX2022-12-01
00840269531859LPLa Pointique International, Ltd.KOX2022-12-01