Ti-MESH

GUDID 04042301097590

Ti-MESH 6"x 6" Extralight 16g/m²

pfm medical titanium gmbh

Abdominal hernia surgical mesh, composite-polymer
Primary Device ID04042301097590
NIH Device Record Key4e68858a-db8a-432f-bb77-785d62671131
Commercial Distribution StatusIn Commercial Distribution
Brand NameTi-MESH
Version Model Number6000311
Company DUNS344675942
Company Namepfm medical titanium gmbh
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104042301097583 [Primary]
GS104042301097590 [Package]
Contains: 04042301097583
Package: Box [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-09
Device Publish Date2021-11-01

On-Brand Devices [Ti-MESH]

04042301117809Ti-MESH 12" X 12" Strong 65g/m²
04042301117793Ti-MESH 6' X 8" Strong 65g/m²
04042301137173Ti-MESH 6" X 6"Strong 65g/m²
04042301102775Ti-MESH 4" X 6" Strong 65g/m²
04042301097637Ti-MESH 6" X 8" Extralight 16g/m²
04042301097590Ti-MESH 6"x 6" Extralight 16g/m²

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