Tissue Punch R2STP40

GUDID 08809728990714

Common Ø4.0

Megagen Implant Co. Ltd

Fixture/appliance dental drill bit, reusable
Primary Device ID08809728990714
NIH Device Record Keyeca26862-e3af-4dda-85b1-fe66ccc5b4c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTissue Punch
Version Model NumberR2STP40
Catalog NumberR2STP40
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
GS108809728990714 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


[08809728990714]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-12
Device Publish Date2023-07-04

On-Brand Devices [Tissue Punch]

08806388238897Common Ø2.5
08806388238880Common Ø7/ L=14
08806388238873Common Ø6/ L=14
08806388238866Common Ø5/ L=14
08806388238859Common Ø4/ L=14
08806388238842Common Ø3/ L=14
08809728990714Common Ø4.0
08809985664694Ø3.3/ Narrow
08800292995006Ø3.3/ Narrow

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.