FDA.reportPublic FDA data

EFFERGRIP ADHESIVE 2.5OZ TUBE 12

Primary DI
10814832010314
Brand
EFFERGRIP ADHESIVE 2.5OZ TUBE 12
Company
MEDTECH PRODUCTS INC.
Model
10814832010314
Device description
EFFERGRIP ADHESIVE 2.5OZ TUBE 12
Published
2022-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOLAdhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOLAdhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide HomopolymerDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814832010314PackageGS11In Commercial Distribution
00814832010317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081483201031410814832010314
00814832010317008148320103178148320103170814832010317

GMDN Terms#

Term, Definition table
TermDefinition
Carboxymethylcellulose sodium denture adhesiveAn adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-925-5374xx@xx.com

Regulatory Flags#

DUNS number
060272465
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08711744032548The Doctor's10304502020-12-08
00042037799229The Doctor's 79922B2020-07-14
00042037799328The Doctor's79932E2020-12-08
00075137000148Compound W®NitroFreeze Yellow CWUS009101N/A2020-01-16
00075137000155Wartner®WPUS0011012020-01-13
00075137440340Compound W®CW017201, CW0121052016-09-16
00075137530058Compound W®CW017201, CW0171052016-09-16
00678112653218Clear Eyes®CE063404, CE063104 2016-09-16
00814832010300EFFERGRIP ADHESIVE 1.5OZ TUBE 24108148320103072022-10-07
00814832010317EFFERGRIP ADHESIVE 2.5OZ TUBE 12108148320103142022-10-07
00814832015862EFFDNT ORIG 44CT TAB 6108148320158692022-11-16
00814832015879EFFERDENT ORIGINAL 102CT TAB 6108148320158762022-11-17
00814832015886EFFDNT ORIG 126CT TAB 6108148320158832022-09-28
00814832015893EFFDNT PLUS MNT 44CT TAB 6108148320158902022-11-16
00814832015909EFFDNT PLUS MNT 90CT TAB 6108148320159062022-11-16
00814832015916EFFDNT PLUS MNT 126CT TAB 6 108148320170542022-09-28
00814832015923EFFERDENT PM 90CT TAB 6108148320159202022-11-17
00814832015930EFFDNT ORIG 252ct CLUB (2x126CT) TAB 12108148320159372022-09-28
00814832017354EFFDNT PM 126CT TAB 6108148320173512022-09-28
07392222170504The Doctor's70502020-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EBRE540011630Qu-connectorbredent GmbH & Co. KGKOL2023-09-07
EBRE540011639Qu-connectorbredent GmbH & Co. KGKOL2023-09-07
00814832010300EFFERGRIP ADHESIVE 1.5OZ TUBE 24Medtech Products Inc.KOL2022-10-07
00814832010317EFFERGRIP ADHESIVE 2.5OZ TUBE 12Medtech Products Inc.KOL2022-10-07
10814832010307EFFERGRIP ADHESIVE 1.5OZ TUBE 24MEDTECH PRODUCTS INC.KOL2022-10-07
EBRE540011850DTK adhesive assortmentbredent GmbH & Co. KGKOL2016-09-27
EBRE540011859DTK adhesive assortmentbredent GmbH & Co. KGKOL2016-09-27
EBRE540011950DTK adhesive refill packbredent GmbH & Co. KGKOL2016-09-22
EBRE540011959DTK adhesive refill packbredent GmbH & Co. KGKOL2016-09-22