Implant Carrier ICWH2538OS

GUDID 08806388262502

Megagen Implant Co. Ltd

Fixture/appliance dental drill bit, reusable
Primary Device ID08806388262502
NIH Device Record Key20f40a4d-b93e-47d6-adb5-7d9811f27bf0
Commercial Distribution StatusIn Commercial Distribution
Brand NameImplant Carrier
Version Model NumberICWH2538OS
Catalog NumberICWH2538OS
Company DUNS687388178
Company NameMegagen Implant Co. Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806388262502 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


[08806388262502]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-17
Device Publish Date2023-11-09

On-Brand Devices [Implant Carrier]

08806388267217Octa 2.1/ Regular
08806388267200Octa 2.5/ Regular
08806388220380ST Regular/ Hex2.1
08806388220373Common Narrow/ Hex1.7
08809728993845R2 Octa 2.5/ Regular
08809728993838R2 Octa 2.1/ Regular
08809854020002Common Narrow/ Hex2.3
08809931181534ICWO2530
08809931181527ICWO2530H
08806388262526ICWH2711CT
08806388262519ICRH2221CT
08806388262502ICWH2538OS
08806388262496ICRH2127OS
08806388270422ICWT43RT
08806388270378ICWT50RT
08806388270361ICRT35RT
08806388262489ICWH2624
08806388246489ICRSBLH
08806388246472ICRSBNH
08806388246465ICRSBL2
08806388246458ICRSBN
08806388244522ICRH2523O
08806388244515ICRH2523HO

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