71935642

GUDID 00885556717424

DOUBLE OFFSET BROACH HANDLE RIGHT

Smith & Nephew, Inc.

Orthopaedic broach

• Primary Device ID: 00885556717424
• NIH Device Record Key: 678c22b0-8ab6-40b4-96e1-a5b96ff3352f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 71935642
• Catalog Number: 71935642
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556717424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123598

FDA Product Code

• JDG: Prosthesis, hip, femoral component, cemented, metal

Sterilization

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

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

[00885556717424]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-20
• Device Publish Date: 2018-08-20

Devices Manufactured by Smith & Nephew, Inc.

• 00885556917442 - CORIOGRAPH: 2024-11-15 CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE
• 00885556919620 - R3: 2024-11-14 R3 HEX ADAPTER
• 00885556919637 - R3: 2024-11-14 MAGNETIC T-HANDLE SOCKET WRENCH
• 00885556919613 - R3: 2024-11-12 OFFSET CUP IMPACTOR
• 00885556000908 - Legion: 2024-11-05 1 Degree Varus/Valgus Recut Block
• 00885556000915 - Legion: 2024-11-05 2 Degree Varus/Valgus Recut Block
• 00885556920640 - NA: 2024-11-05 4.5mm Proximal Tibia Plate 4 Hole EVOS
• 00885556920831 - Legion: 2024-11-05 Monolithic CR DF Trial Sz 3-4 - 18mm