SL-PLUS/SLR-PLUS/CPS-PLUS/ GERADSCHAFT-PLUS 75002319

GUDID 07611996013788

SL/SLR/CPS/GERADSCHAFT-PLUS SLAP HAMMER

Smith & Nephew, Inc.

Surgical mallet

• Primary Device ID: 07611996013788
• NIH Device Record Key: db198128-5997-4b97-8bb8-348262241deb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SL-PLUS/SLR-PLUS/CPS-PLUS/ GERADSCHAFT-PLUS
• Version Model Number: 75002319
• Catalog Number: 75002319
• 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
• 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	07611996013788 [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

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

[07611996013788]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-11-25

On-Brand Devices [SL-PLUS/SLR-PLUS/CPS-PLUS/ GERADSCHAFT-PLUS]

• 07611996013849: SL/SLR/CPS/GERADSCHAFT EXTRACTION SCREW
• 07611996013818: SL/SLR/CPS/GERADSCHAFT-PLUS BOX CHISEL
• 07611996013788: SL/SLR/CPS/GERADSCHAFT-PLUS SLAP HAMMER