FDA.report

UNI-SOLVE Wipes

Primary DI
00040565115658
Brand
UNI-SOLVE Wipes
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
402300
Catalog number
402300
Device description
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
00040565115658PackageGS125In Commercial Distribution
30040565115659PackageGS120In Commercial Distribution
00040565111803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00040565115658000405651156580405651156580040565115658
3004056511565930040565115659
00040565111803000405651118030405651118030040565111803

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

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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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