SynPOR 08510541S

GUDID H98008510541S0

SYNPOR ORBITAL FLOOR PLATE 30MM/0.8MM THICK-STERILE

SYNTHES (U.S.A.) LP

Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: H98008510541S0
• NIH Device Record Key: 85f89a3d-9e03-4be9-a877-4a844de21c4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynPOR
• Version Model Number: 08.510.541S
• Catalog Number: 08510541S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587026152 [Primary]
HIBCC	H98008510541S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051879

FDA Product Code

• FTL: Mesh, surgical, polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-14

On-Brand Devices [SynPOR]

• H98008520231S0: SYNPOR SMOOTH TI REINFORCED FAN PL FIXTN H/1.5MM THK-STER
• H98008520230S0: SYNPOR SMOOTH TI REINFORCED FAN PLATE 1.5MM THICK-STERILE
• H98008520221S0: SYNPOR SMOOTH TI REINFORCED FAN PL FIXTN H/0.8MM THK-STER
• H98008520220S0: SYNPOR SMOOTH TI REINFORCED FAN PLATE 0.8MM THICK-STERILE
• H98008520131S0: SYNPOR TI REINFORCED FAN PLATE FIXTN HOLES/1.5MM THICK-STER
• H98008520130S0: SYNPOR TI REINFORCED FAN PLATE 1.5MM THICK-STERILE
• H98008520121S0: SYNPOR TI REINFORCED FAN PLATE FIXTN HOLES/0.8MM THICK-STER
• H98008520120S0: SYNPOR TI REINFORCED FAN PLATE 0.8MM THICK-STERILE
• H98008510646S0: SYNPOR SMOOTH FAN PLATE 35MM/0.8MM THICK-STERILE
• H98008510642S0: SYNPOR SMOOTH ORBITAL FLOOR PLATE 35MM/0.8MM THK-STERILE
• H98008510641S0: SYNPOR SMOOTH ORBITAL FLOOR PLATE 30MM/0.8MM THK-STERILE
• H98008510640S0: SYNPOR SMOOTH ORBITAL FLOOR PLATE 24MM/0.8MM THK-STERILE
• H98008510547S0: SYNPOR FAN PLATE 35MM/1.5MM THICK-STERILE
• H98008510546S0: SYNPOR FAN PLATE 35MM/0.8MM THICK-STERILE
• H98008510545S0: SYNPOR ORBITAL FLOOR PLATE 35MM/1.5MM THICK-STERILE
• H98008510544S0: SYNPOR ORBITAL FLOOR PLATE 30MM/1.5MM THICK-STERILE
• H98008510543S0: SYNPOR ORBITAL FLOOR PLATE 24MM/1.5MM THICK-STERILE
• H98008510542S0: SYNPOR ORBITAL FLOOR PLATE 35MM/0.8MM THICK-STERILE
• H98008510541S0: SYNPOR ORBITAL FLOOR PLATE 30MM/0.8MM THICK-STERILE
• H98008510540S0: SYNPOR ORBITAL FLOOR PLATE 24MM/0.8MM THICK-STERILE
• H98008510220S0: SYNPOR SMOOTH SQUARE SHEET 50MMX50MM/0.8MM THICK-STERILE
• H98008510140S0: SYNPOR SQUARE SHEET-STERILE 50MMX50MM/3.0MM THICK
• H98008510130S0: SYNPOR SQUARE SHEET-STERILE 50MMX50MM/1.5MM THICK
• H98008510120S0: SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK
• H98008510110S0: SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.45MM THICK