In-Fix E0016897-1

GUDID 00885556778197

CANNULATED SINGLE POINT TROCAR

Smith & Nephew, Inc.

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