FRA 389049

GUDID H9813890490

SMALL STATURE FRA TRIAL SPACER HANDLE

SYNTHES (U.S.A.) LP

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: H9813890490
• NIH Device Record Key: c8be87e3-ec81-410b-8885-019f162db949
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRA
• Version Model Number: 389.049
• Catalog Number: 389049
• 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
• 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	10705034774169 [Primary]
HIBCC	H9813890490 [Secondary]

FDA Product Code

• GDZ: HANDLE, SCALPEL

Sterilization

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

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

Moist Heat or Steam Sterilization

[H9813890490]

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

On-Brand Devices [FRA]

• H9813890500: SMALL STATURE FRA IMPLANT HOLDER
• H9813890490: SMALL STATURE FRA TRIAL SPACER HANDLE
• H9813890480: SMALL STATURE FRA TRIAL SPACER ANGLED 11MM
• H9816900250: FRA SPACER INSTRUMENT SET GRAPHIC CASE