EP-FIT PLUS 75009600

GUDID 00885556487969

EP-FIT SPUTNIK FOR PRECIMED IMPACTOR

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00885556487969
• NIH Device Record Key: bcbe6fd1-2823-4964-b07c-2801e04eccab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EP-FIT PLUS
• Version Model Number: 75009600
• Catalog Number: 75009600
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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: 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556487969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123598

FDA Product Code

• LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Sterilization

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

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

[00885556487969]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-09
• Device Publish Date: 2015-11-25

Devices Manufactured by Smith & Nephew, Inc.

• 00885556414965 - REFLECTION: 2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
• 00885556533574 - REFLECTION: 2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 66-68MM OUTER DIAMETER SIZE J ETO
• 00885556533581 - REFLECTION: 2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
• 00885556535059 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE ANTEVERTED +4MM 50-52MM OUTER DIAMETER E ETO
• 00885556535073 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E ETO
• 00885556535080 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
• 00885556535097 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETERSIZE G ETO
• 00885556535103 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 62-64MM OUTER DIAMETER SIZE H ETO