FDA.report

Maxill Chromamax High Precision Chromatic Alginate

Primary DI
00060705537751
Brand
Maxill Chromamax High Precision Chromatic Alginate
Company
MAXILL, INC.
Model
53775
Published
2018-09-18
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

Product Codes

CodeName
ELWMaterial, Impression

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00060705537751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00060705537751000607055377510607055377510060705537751

GMDN Terms

TermDefinition
Alginate dental impression materialA material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
079343581
Device count
1
DM exempt
false
Premarket exempt
false
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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D8926070553275C21maxill Frames Eyewear Adult6070553275C22022-11-14
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