Flowers Mandibular Glove® FMG-VL

GUDID M724FMGVL1

Chin Implant

IMPLANTECH ASSOCIATES, INC.

Chin prosthesis
Primary Device IDM724FMGVL1
NIH Device Record Key1de03702-03b4-4a93-843d-e65bfc85b0ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlowers Mandibular Glove®
Version Model NumberSize: Large
Catalog NumberFMG-VL
Company DUNS784664955
Company NameIMPLANTECH ASSOCIATES, 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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-733-0833
Emailinfo@implantech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724FMGVL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FWPProsthesis, Chin, Internal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-15
Device Publish Date2015-09-24

On-Brand Devices [Flowers Mandibular Glove®]

M724FMGVXS1Chin Implant
M724FMGVXL1Chin Implant
M724FMGVS1Chin Implant
M724FMGVM1Chin Implant
M724FMGVL1Chin Implant

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