Sub. Hex. Angulated Gauge

GUDID 08809471725595

Cowellmedi Co.,Ltd

Dental implantation depth/angle gauge, reusable
Primary Device ID08809471725595
NIH Device Record Keyade6ee34-c597-4c87-b5e9-874fa06cef50
Commercial Distribution StatusIn Commercial Distribution
Brand NameSub. Hex. Angulated Gauge
Version Model Number2SAG254
Company DUNS688753763
Company NameCowellmedi 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809471725595 [Primary]

FDA Product Code

EILGauge, Depth, Instrument, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809471725595]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-27
Device Publish Date2018-05-24

On-Brand Devices [Sub. Hex. Angulated Gauge]

088094717255952SAG254
088094717255882SAG252
088094717255712SAG154
088094717255642SAG152

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