Unit Assembly 9645 FB

GUDID D04020011540

A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This is a reusable device.

WHIP-MIX CORPORATION

Facebow
Primary Device IDD04020011540
NIH Device Record Keya9575ac6-b302-4b41-ad7d-44a6c656f9ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnit Assembly 9645 FB
Version Model Number20011540
Company DUNS006385173
Company NameWHIP-MIX CORPORATION
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
HIBCCD04020011540 [Primary]

FDA Product Code

KCRFacebow

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-06
Device Publish Date2023-10-27

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D04020002950 - Unit-Assy Slidematic2023-11-06 A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the t
D04020011540 - Unit Assembly 9645 FB2023-11-06 A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This is a reusable device.
D04020011540 - Unit Assembly 9645 FB2023-11-06 A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the

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