FDA.reportPublic FDA data

GluGone Adhesive Remover, 0.67 oz.

Primary DI
10854137001730
Brand
GluGone Adhesive Remover, 0.67 oz.
Company
CHEMENCE MEDICAL PRODUCTS, INC.
Model
GG80148
Catalog number
GG80148
Device description
0.67 OZ
Published
2022-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
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
10854137001730PackageGS148In Commercial Distribution
00854137001733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085413700173010854137001730
00854137001733008541370017338541370017330854137001733

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18446334583customerservice@chemence.com

Regulatory Flags#

DUNS number
079163089
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854137001754exofin Fusion Skin Closure System SourceMark, 60cmM1244M12442022-05-17
10854137001808Exofin Fusion Skin Closure System SourceMark, 6cmM1266M12662022-05-17
00854137001610Exofin Fusion Skin Closure System, 6cmEF704062022-05-13
00854137001511exofin Fusion Skin Closure System, 60cmEF70466EF704662022-02-14
30854137001147exofin HVTA ST&G, 1g Box of 10EX70407EX704072022-02-14
10854137001655Premier Pro Exofin Precision Pen34752021-12-08
00854137001641eXofin Precision Pen High Viscosity Topical Skin AdhesiveEP704122021-11-10
10854137001679Premier Pro Exofin HVTA 347034702021-11-08
10854137001624eXofin High Viscosity Topical Skin AdhesiveEX704102021-10-29
00854137001481Exofin XLEX720062019-05-30
10854137001235Exofin Fusion Skin Closure System22cmEF704012017-10-25
20854137001195OctylbondM1201M12012016-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810040130465Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00810040130472Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00810040135538Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00850002835199Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00850002835205Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00850002835557Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00850002835564Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00850004779057Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00856253007361Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00856253007378Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00856253007385Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00856253007392Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
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