TiMESH

GUDID 04042301097606

Ti-Mesh 6" X 6" Light 35g/m²

pfm medical titanium gmbh

Pelvic organ prolapse surgical mesh, composite-polymer

• Primary Device ID: 04042301097606
• NIH Device Record Key: fa606046-b360-42ee-9dfc-9d5425b02c82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiMESH
• Version Model Number: 6000312
• Company DUNS: 344675942
• Company Name: pfm medical titanium gmbh
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: Regulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04042301097606 [Primary]
GS1	04042301097613 [Package]; Package: Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031225

FDA Product Code

• OXJ: Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-10-21
• Device Publish Date: 2020-06-02

On-Brand Devices [TiMESH]

• 04042301144348: Ti-Mesh 1.4" X 4" Strong 65g/m²
• 04042301144324: Ti-Mesh 1.4" X 4" Light 35g/m²
• 04042301097668: Ti-Mesh 12" X 12" Light 35g/m²
• 04042301097651: Ti-Mesh 6" X 8" Light 35g/m²
• 04042301097576: Ti-Mesh 4" X 6" Light 35 g/m²
• 04042301097552: Ti-Mesh 4" X 6" Extra Light 16 g/m²
• 04042301097606: Ti-Mesh 6" X 6" Light 35g/m²