FDA.report

3M™ Imprint™

Primary DI
04054596648265
Brand
3M™ Imprint™
Company
3M Deutschland GmbH
Model
71487
Catalog number
71487
Device description
3M™ Imprint™ 4 Regular VPS Impression Material Refill, 71487
Published
2022-08-02
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
ELWMATERIAL, IMPRESSION

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04054596648265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04054596648265040545966482654054596648265

GMDN Terms

TermDefinition
Dental material mixing nozzle, non-sterileA non-sterile device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
315731711
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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