ACF 03841052

GUDID 07611819473119

ACF HOLDER

SYNTHES (U.S.A.) LP

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: 07611819473119
• NIH Device Record Key: 26ac46e7-4700-48f9-9cb9-6b47fa88a2cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACF
• Version Model Number: 03.841.052
• Catalog Number: 03841052
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	07611819473119 [Direct Marking]
GS1	10705034732329 [Primary]
HIBCC	H981038410520 [Secondary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

[07611819473119]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-12-31

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• 07611819738584: ACF DETACHABLE TRIAL SPACER LORDOTIC 6MM
• 07611819738577: ACF DETACHABLE TRIAL SPACER LORDOTIC 5MM
• 07611819233911: ACF TRIAL SPACER HANDLE
• 07611819738744: ACF DETACHABLE TRIAL SPACER CONVEX 10MM
• 07611819738720: ACF DETACHABLE TRIAL SPACER CONVEX 9MM
• 07611819738706: ACF DETACHABLE TRIAL SPACER CONVEX 8MM
• 07611819738683: ACF DETACHABLE TRIAL SPACER CONVEX 7MM
• 07611819738652: ACF DETACHABLE TRIAL SPACER CONVEX 6MM
• 07611819738645: ACF DETACHABLE TRIAL SPACER CONVEX 5MM
• 07611819738638: ACF DETACHABLE TRIAL SPACER LORDOTIC 10MM
• 07611819738621: ACF DETACHABLE TRIAL SPACER LORDOTIC 9MM
• 07611819978157: IMPLANT HOLDER FOR ACF ALLOGRAFT SPACERS
• H9813963840: ACF SPACER IMPLANT HOLDER
• H9813890780: SPN CORRECTION ACF EXTENDED IMPLANT HOLDER
• H9813890770: SPN CORRECTION ACF TRIAL SPACER HANDLE
• 07611819473119: ACF HOLDER
• H9816900300: ANTERIOR CERVICAL FUSION INSTRUMENT SET GRAPHIC CASE
• H9813048240: ACF GRAPHIC CASE