IMPRESS-RITE IMP-8003T

GUDID 10818524020407

M&S DENTAL IMPRESS-RITE SHM LIGHT BODY TUBE KIT

CROWN DELTA CORPORATION

Silicone dental impression material Silicone dental impression material
Primary Device ID10818524020407
NIH Device Record Key821086f0-3a86-4b30-bedf-543bedd3dc4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPRESS-RITE
Version Model NumberIMP-8003T
Catalog NumberIMP-8003T
Company DUNS030479000
Company NameCROWN DELTA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100818524020400 [Primary]
GS110818524020407 [Package]
Contains: 00818524020400
Package: CASE [10 Units]
In Commercial Distribution

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-05

On-Brand Devices [IMPRESS-RITE]

10818524020674M&S DENTAL IMPRESS-RITE SHM HEAVY BODY FAST SET - 50 mL CARTRIDGE
00818524020639M&S DENTAL IMPRESS-RITE HP TEMPORARY CEMENT MIXING TIP 20 PER BAG
10818524020599M&S DENTAL IMPRESS-RITE SHM LIGHT BODY REGULAR SET - 50 mL CART
10818524020575M&S DENTAL IMPRESS-RITE SHM HEAVY BODY REGULAR SET - 50 mL CART
00818524020431M&S DENTAL IMPRESS-RITE SHM MEDIUM BODY TUBE KIT
00818524020424M&S DENTAL IMPRESS-RITE PUTTY KIT 50D FAST SET
10818524020407M&S DENTAL IMPRESS-RITE SHM LIGHT BODY TUBE KIT
00818524020394M&S DENTAL IMPRESS-RITE PUTTY KIT 50D REGULAR SET
10818524020384M&S DENTAL IMPRESS-RITE SHM HEAVY BODY REGULAR SET TUBE KIT
20818524020367M&S DENTAL IMPRESS-RITE SHM MONOPHASE REGULAR SET - 50 mL CART
20818524020343M&S DENTAL IMPRESS-RITE SHM LIGHT BODY FAST SET - 50 mL CART
20818524020336M&S DENTAL IMPRESS-RITE SHM LIGHT BODY REGULAR SET - 50 mL CART
10818524020322M&S DENTAL IMPRESS-RITE SHM MONOPHASE TUBE KIT
20818524020305M&S DENTAL IMPRESS-RITE SHM MONOPHASE FAST SET - 50 mL CART
20818524020268M&S DENTAL IMPRESS-RITE SHM MONOPHASE REGULAR SET - 50 mL CART
20818524020237M&S DENTAL IMPRESS-RITE SHM MEDIUM BODY REGULAR SET - 50 mL CART
20818524020220M&S DENTAL IMPRESS-RITE SHM MEDIUM BODY FAST SET - 50 mL CART
20818524020183M&S DENTAL IMPRESS-RITE SHM HEAVY BODY FAST SET 50 mL CART
10818524020629M&S DENTAL IMPRESS-RITE 380 HEAVY BODY REGULAR SET

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