CONVENE 71362800

GUDID 03596010306548

CONVENE ASSEMBLY TOOL

Smith & Nephew, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 03596010306548
• NIH Device Record Key: d9e359b9-a56f-43e8-b1e1-33a086c76de6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONVENE
• Version Model Number: 71362800
• Catalog Number: 71362800
• 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)821-5700
• 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	03596010306548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121393

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

[03596010306548]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [CONVENE]

• 03596010306548: CONVENE ASSEMBLY TOOL
• 03596010306555: CONVENE INSTRUMENT TRAY
• 03596010411853: CONVENE BIPOLAR LINER 28MM ID 57-60MM OD
• 03596010409294: CONVENE BIPOLAR LINER 28MM ID 43-46MM OD
• 03596010306869: CONVENE BIPOLAR LINER 28MM ID 52-56MM OD
• 03596010306852: CONVENE BIPOLAR LINER 28MM ID 47-51MM OD
• 03596010306838: CONVENE BIPOLAR LINER 26MM ID 38-42MM OD