Rebilda Form

GUDID E22114081

VOCO GmbH

Dental matrix band, single-use
Primary Device IDE22114081
NIH Device Record Key10c3c45a-16cf-4abc-83c9-1ba70572fe1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRebilda Form
Version Model Number1408
Company DUNS316699578
Company NameVOCO GmbH
Device Count20
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone999-999-9999
Emailxxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE2211408 [Unit of Use]
HIBCCE22114081 [Primary]

FDA Product Code

EHQCusp, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-11-26

On-Brand Devices [Rebilda Form]

E221140911409
E221140811408
E221140711407

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