FDA.report

EPITEX®

Primary DI
20386040011348
Brand
EPITEX®
Company
Gc America Inc.
Model
473021
Catalog number
473021
Device description
EPITEX® Refill Packages Contains: 1 Reel Medium (Green)
Published
2022-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EHMSTRIP, POLISHING AGENT

Product Code Classifications

CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20386040011348PackageGS15In Commercial Distribution
10386040011341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2038604001134820386040011348
1038604001134110386040011341

GMDN Terms

TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store away from high temperature or humidity.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags

DUNS number
005473608
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

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