SynPOR 08510542S

GUDID H98008510542S0

SYNPOR ORBITAL FLOOR PLATE 35MM/0.8MM THICK-STERILE

SYNTHES (U.S.A.) LP

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: H98008510542S0
• NIH Device Record Key: c17cdb2b-c7b9-4587-b720-cec6fe4dcb2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynPOR
• Version Model Number: 08.510.542S
• Catalog Number: 08510542S
• 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	10887587026176 [Primary]
HIBCC	H98008510542S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051879

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

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