CS 71364020

GUDID 00885556028513

CALCAR REAMER X-SMALL

Smith & Nephew, Inc.

Bone-resection orthopaedic reamer, reusable

• Primary Device ID: 00885556028513
• NIH Device Record Key: 3d50577f-e60f-4c09-b73b-d6eb2154a6e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS
• Version Model Number: 71364020
• Catalog Number: 71364020
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• 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
• 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	00885556028513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123598

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

[00885556028513]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [CS]

• 00885556028513: CALCAR REAMER X-SMALL
• 00885556026335: CS TRIAL HEAD 22MM +0
• 00885556026038: CS FEM INST TRAY #2
• 00885556025611: CS TRIAL HEAD 26MM +5
• 00885556025208: CS TRIAL HEAD 26MM +0
• 00885556024973: CS TRIAL HEAD 22MM +3
• 00885556023945: CS TRIAL HEAD 22MM -3
• 00885556022832: CS TRIAL HEAD 26MM -5