OPTILINK 42231645

GUDID H679422316450

5.0MM CANN VAL SCREW OPTILINK(TM)/45MM

SYNTHES (U.S.A.) LP

Internal orthopaedic fixation system, cerclage wire/cable, sterile

• Primary Device ID: H679422316450
• NIH Device Record Key: 71758124-787e-46be-a5a3-efad20887735
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTILINK
• Version Model Number: 42.231.645
• Catalog Number: 42231645
• 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: false
• 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
• 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	10886982259097 [Primary]
HIBCC	H679422316450 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162124

FDA Product Code

• JDQ: Cerclage, fixation

Sterilization

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

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

[H679422316450]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-29
• Device Publish Date: 2019-10-21

On-Brand Devices [OPTILINK]

• H67942231310S0: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/110MM-STERILE
• H67942231305S0: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/105MM-STERILE
• H67942231300S0: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/100MM-STERILE
• H67942231295S0: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/95MM-STERILE
• H679422310180: 5.0MM PERIPR VAL SCR/18MM OPTILINK(TM)/SLF-TPNG/STRDRV
• H679422310160: 5.0MM PERIPR VAL SCR/16MM OPTILINK(TM)/SLF-TPNG/STRDRV
• H679422310140: 5.0MM PERIPR VAL SCR/14MM OPTILINK(TM)/SLF-TPNG/STRDRV
• H679422310120: 5.0MM PERIPR VAL SCR/12MM OPTILINK(TM)/SLF-TPNG/STRDRV
• H679422310100: 5.0MM PERIPR VAL SCR/10MM OPTILINK(TM)/SLF-TPNG/STRDRV
• H679422312900: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/90MM
• H679422312850: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/85MM
• H679422312800: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/80MM
• H679422312750: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/75MM
• H679422312700: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/70MM
• H679422312650: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/65MM
• H679422312600: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/60MM
• H679422312550: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/55MM
• H679422312500: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/50MM
• H679422312480: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/48MM
• H679422312460: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/46MM
• H679422312440: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/44MM
• H679422312420: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/42MM
• H679422312400: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/40MM
• H679422312380: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/38MM
• H679422312360: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/36MM
• H679422312340: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/34MM
• H679422312320: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/32MM
• H679422312300: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/30MM
• H679422312280: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/28MM
• H679422312260: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/26MM
• H679422312240: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/24MM
• H679422312220: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/22MM
• H679422312200: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/20MM
• H679422312180: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/18MM
• H679422312160: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/16MM
• H679422312140: 5.0MM VAL SCREW/OPTILINK(TM) SLF-TPNG/STRDRV/14MM
• H67942231710S0: 5.0MM CANN VAL SCREW OPTILINK(TM)/110MM/STERILE
• H67942231705S0: 5.0MM CANN VAL SCREW OPTILINK(TM)/105MM/STERILE
• H67942231700S0: 5.0MM CANN VAL SCREW OPTILINK(TM)/100MM/STERILE
• H67942231695S0: 5.0MM CANN VAL SCREW OPTILINK(TM)/95MM/STERILE
• H67942231018S0: 5.0MM PERIPR VAL SCR/18MM OPTILINK(TM)/STRDRV/STERILE
• H67942231016S0: 5.0MM PERIPR VAL SCR/16MM OPTILINK(TM)/STRDRV/STERILE
• H67942231014S0: 5.0MM PERIPR VAL SCR/14MM OPTILINK(TM)/STRDRV/STERILE
• H67942231012S0: 5.0MM PERIPR VAL SCR/12MM OPTILINK(TM)/STRDRV/STERILE
• H67942231010S0: 5.0MM PERIPR VAL SCR/10MM OPTILINK(TM)/STRDRV/STERILE
• H67942231008S0: 5.0MM PERIPR VAL SCR/8MM OPTILINK(TM)/STRDRV/STERILE
• H679422316900: 5.0MM CANN VAL SCREW OPTILINK(TM)/90MM
• H679422316850: 5.0MM CANN VAL SCREW OPTILINK(TM)/85MM
• H679422316800: 5.0MM CANN VAL SCREW OPTILINK(TM)/80MM
• H679422316750: 5.0MM CANN VAL SCREW OPTILINK(TM)/75MM