In-Fix E0016897-1

GUDID 00885556778197

CANNULATED SINGLE POINT TROCAR

Smith & Nephew, Inc.

Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00885556778197
• NIH Device Record Key: d8895c96-40d6-49c3-8bdf-c3f853c6bc66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In-Fix
• Version Model Number: E0016897-1
• Catalog Number: E0016897-1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556778197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123055

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

[00885556778197]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-27
• Device Publish Date: 2020-02-19

On-Brand Devices [In-Fix]

• 00885556771051: LONG T8 DRIVER WITH AO QUICK CONNECT
• 00885556771037: LONG T7 DRIVER WITH AO QUICK CONNECT
• 00885556771020: LONG T6 DRIVER WITH AO QUICK CONNECT
• 00885556778197: CANNULATED SINGLE POINT TROCAR
• 00885556795767: MODIFIED T8 DRIVER WITH AO QUICK CONNECT
• 00885556795750: MODIFIED T7 DRIVER WITH AO QUICK CONNECT
• 00885556795743: MODIFIED T6 DRIVER WITH AO QUICK CONNECT
• 00885556872864: MODIFIED T8 DRIVER WITH AO QUICK CONNECT
• 00885556872857: MODIFIED T7 DRIVER WITH AO QUICK CONNECT
• 00885556872840: MODIFIED T6 DRIVER WITH AO QUICK CONNECT
• 00885556787328: LONG T8 DRIVER WITH AO QUICK CONNECT
• 00885556787311: LONG T7 DRIVER WITH AO QUICK CONNECT
• 00885556787304: LONG T6 DRIVER WITH AO QUICK CONNECT