DEVICE: Affinity™ Heavy Body Fast Set w/o tips 2pk (07540172010900)

Download: XML | JSON

Device Identifier (DI) Information

Affinity™ Heavy Body Fast Set w/o tips 2pk
023405W
023405W
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
07540172010900
GS1
1
VPS Impression Material
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Silicone dental impression material An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ELW MATERIAL, IMPRESSION
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 65 and 75 Degrees Fahrenheit
Storage Environment Temperature: between 18 and 24 Degrees Celsius
Special Storage Condition, Specify: Min Relative Humidity. Ensure Adequate Ventilation
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Total Volume: 50 Milliliter
Device Size Text, specify: 2x50ml cartridge
CLOSE

Device Status

In Commercial Distribution
September 16, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)265-3444
info@clinicianschoice.com
CLOSE