FDA.reportPublic FDA data

Skinister Medical

Primary DI
00810049490676
Brand
Skinister Medical
Company
Delta Molding LLC
Model
SR4S
Device description
Silicone-based adhesive remover. 4oz bottle with spray top.
Published
2024-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOXSolvent, Adhesive Tape

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOXSolvent, Adhesive TapeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810049490676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810049490676008100494906768100494906760810049490676

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)430-7546Info@SkinisterMedical.com

Regulatory Flags#

DUNS number
080190661
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810049490645Skinister MedicalSA4S2024-05-14
00810049490652Skinister MedicalSA2S2024-05-14
00810049490669Skinister MedicalSA1D2024-05-14
00810049490706Skinister MedicalSR2S2024-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344179811MEDLINEMEDLINE INDUSTRIES, INC.KOX2026-05-15
08904428744992OSSEOUS-Cleaning PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428745012OSSEOUS- Adhesion Remover PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428798469OSSEOUS-Cleaning PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428799749OSSEOUS- Adhesion Remover PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
307073877738793M™3M COMPANYKOX2026-02-19
007073875674603M™3M COMPANYKOX2026-02-19
507073875674653M™3M COMPANYKOX2026-02-19
507073877738733M™3M COMPANYKOX2026-02-19
30080196771763MEDLINEMEDLINE INDUSTRIES, INC.KOX2025-05-07
40080196771760MEDLINEMEDLINE INDUSTRIES, INC.KOX2025-05-07
00840270610062MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610369MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610512MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610529MaxtapingOppo Medical Inc.KOX2025-04-01
06950715505625cofoeCofoe Medical Technology Co.,LtdKOX2024-12-09
00810113577784ViveCareVIVE HEALTH LLCKOX2024-09-04
00810113577791ViveCareVIVE HEALTH LLCKOX2024-09-04
10810113577781ViveCareVIVE HEALTH LLCKOX2024-09-04
10810113577798ViveCareVIVE HEALTH LLCKOX2024-09-04
10193489131550MEDLINEMEDLINE INDUSTRIES, INC.KOX2024-07-04
20193489131557MEDLINEMEDLINE INDUSTRIES, INC.KOX2024-07-04
00810049490706Skinister MedicalDelta Molding LLCKOX2024-05-14
10884521738362ANS MEDICALCardinal Health, Inc.KOX2023-05-17
60884521738367ANS MEDICALCardinal Health, Inc.KOX2023-05-17
00850048477063WarriorNPWarriornp LLCKOX2023-03-03
00815991024771BodyMedBOXOUT, LLCKOX2023-02-17
00749756877978DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02
00749756877985DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02
50749756877973DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02