BOFOR/EP-FIT PLUS/PROMOS/MPF 75003282

GUDID 07611996014990

BOFOR/EP-FIT/PROMOS/MPF FLEX.SHAFT

Smith & Nephew, Inc.

Fluted surgical drill bit, reusable

• Primary Device ID: 07611996014990
• NIH Device Record Key: c092db81-796f-4904-971e-0f641af8a989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOFOR/EP-FIT PLUS/PROMOS/MPF
• Version Model Number: 75003282
• Catalog Number: 75003282
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611996014990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123598

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

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

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

[07611996014990]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-22
• Device Publish Date: 2015-11-25

Devices Manufactured by Smith & Nephew, Inc.

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• 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