IH Pick-up Impression Coping AIHPIMH4011

GUDID 08800041351855

SEWON MEDIX IH Pick-up Impression Coping Mini Body Hex Set Product, Ø4.0x13.6x5.6mm

sewon medix Inc.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800041351855
NIH Device Record Key2be0602f-17e7-47a9-8bd3-02f30f819f4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameIH Pick-up Impression Coping
Version Model NumberAIHPIMH4011
Catalog NumberAIHPIMH4011
Company DUNS688731065
Company Namesewon medix Inc.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-224-531-3099
Emailhsong@mydental.com

Device Dimensions

Stent Diameter4.8 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800041351855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-09-10

On-Brand Devices [IH Pick-up Impression Coping]

08800041351923SEWON MEDIX IH Pick-up Impression Coping Regular Body Hex Set Product, Ø4.5x17.5x6.5mm
08800041351916SEWON MEDIX IH Pick-up Impression Coping Regular Body Hex Set Product, Ø4.5x13.5x5.5mm
08800041351862SEWON MEDIX IH Pick-up Impression Coping Mini Body Hex Set Product, Ø4.0x17.6x6.6mm
08800041351855SEWON MEDIX IH Pick-up Impression Coping Mini Body Hex Set Product, Ø4.0x13.6x5.6mm

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