SurgiMesh

GUDID 00850011929063

BG MEDICAL, LLC

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 00850011929063
• NIH Device Record Key: cb21571c-87af-43e0-926f-23d8411242a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiMesh
• Version Model Number: Tintra E-3030
• Company DUNS: 825244135
• Company Name: BG MEDICAL, LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011929063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072974

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-07
• Device Publish Date: 2020-01-30

On-Brand Devices [SurgiMesh]

• 00850011929247: T1418-8XD
• 00850011929230: T1116-8XD
• 00850011929223: T1115-8
• 00850011929216: TEL613-8
• 00850011929209: T613-8S
• 00850011929193: TEALFIL-8
• 00850011929186: T3030
• 00850011929179: T221510
• 00850011929155: T1415
• 00850011929148: T1015
• 00850011929131: T510
• 00850011929124: Tintra OK-1522
• 00850011929117: Tintra OK-1015
• 00850011929100: Tintra CK-10
• 00850011929094: Tintra CK-7
• 00850011929070: Tintra O-2636
• 00850011929063: Tintra E-3030
• 00850011929056: Tintra E-2226
• 00850011929049: Tintra E-1522
• 00850011929032: Tintra R-1415
• 00850011929025: Tintra C-15
• 00850011929018: Tintra C-12
• 00850011929001: Tintra C-10
• 00850011929292: T5050
• 00850011929278: T4040