Screw-ZioCera ABT

GUDID 00810019241208

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00810019241208
NIH Device Record Key6bfa87c1-861c-46e8-af93-865c729c8709
Commercial Distribution StatusIn Commercial Distribution
Brand NameScrew-ZioCera ABT
Version Model NumberETASR
Company DUNS796083090
Company NameHIOSSEN, 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 Numbertrue
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
GS100810019241208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-23
Device Publish Date2019-05-15

On-Brand Devices [Screw-ZioCera ABT]

00810019241208ETASR
00810019241192ETASM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.