CPCS 71362630

GUDID 03596010462862

CPCS INSERTER HANDLE

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting

• Primary Device ID: 03596010462862
• NIH Device Record Key: 9a35c5c5-4e61-46c9-8029-db984be8720f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPCS
• Version Model Number: 71362630
• Catalog Number: 71362630
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010462862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122170

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

[03596010462862]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [CPCS]

• 00885556635278: CPCS OFFSET STEM INSERTER
• 00885556622094: CPCS LOCKING OFFSET STEM INSERTER
• 00885556590324: SYNCERA CPCS PRIMARY INSTRUMENT TRAY
• 03596010462879: CPCS STEM DRIVER
• 03596010467249: CPCS PRIMARY INSTRUMENT TRAY
• 03596010467157: CPCS BROACH SIZE 5
• 03596010467140: CPCS BROACH SIZE 4
• 03596010467133: CPCS BROACH SIZE 3
• 03596010467126: CPCS BROACH SIZE 2
• 03596010467119: CPCS BROACH SIZE 1
• 03596010467102: CPCS BROACH SIZE 0
• 03596010467096: CPCS STARTER BROACH
• 03596010467089: CPCS TRIAL NECK SIZE 3H-4H-5H
• 03596010467072: CPCS TRIAL NECK SIZE 1H-2H
• 03596010467065: CPCS TRIAL NECK SIZE 0H
• 03596010467058: CPCS TRIAL NECK SIZE 3-4-5
• 03596010467041: CPCS TRIAL NECK SIZE 1-2
• 03596010467034: CPCS TRIAL NECK SIZE 0
• 03596010462862: CPCS INSERTER HANDLE
• 03596010462176: CPCS COBALT CHROME PRIM HIGH OFFSET 12/14 TPR SZ 4
• 03596010462015: CPCS COBALT CHROME PRIM STAND OFFSET 12/14 TPR SZ2
• 03596010462008: CPCS COBALT CHROME PRIM STAND OFFSET 12/14 TPR SZ1
• 03596010462138: CPCS COBALT CHROME PRIMARY HIGH OFFSET 12/14 TAPER SIZE 0
• 03596010473400: CPCS COBALT CHROME PRIMARY STANDARD OFFSET 12/14 XSM
• 03596010467027: CPCS DISTAL CENTRALIZER SIZE 18MM
• 03596010467010: CPCS DISTAL CENTRALIZER SIZE 16MM
• 03596010467003: CPCS DISTAL CENTRALIZER SIZE 14MM
• 03596010466990: CPCS DISTAL CENTRALIZER SIZE 12MM
• 03596010466983: CPCS DISTAL CENTRALIZER SIZE 10MM
• 03596010466976: CPCS DISTAL CENTRALIZER SIZE 8MM
• 03596010462183: CPCS COBALT CHROME PRIMARY HIGH OFFSET 12/14 TAPER SIZE 5
• 03596010462169: CPCS COBALT CHROME PRIMARY HIGH OFFSET 12/14 TAPER SIZE 3
• 03596010462152: CPCS COBALT CHROME PRIMARY HIGH OFFSET 12/14 TAPER SIZE 2
• 03596010462145: CPCS COBALT CHROME PRIMARY HIGH OFFSET 12/14 TAPER SIZE 1
• 03596010462046: CPCS COBALT CHROME PRIMARY STANDARD OFFSET 12/14 TAPER SIZE
• 03596010462039: CPCS COBALT CHROME PRIMARY STANDARD OFFSET 12/14 TAPER SIZE
• 03596010462022: CPCS COBALT CHROME PRIMARY STANDARD OFFSET 12/14 TAPER SIZE
• 03596010461995: CPCS COBALT CHROME PRIMARY STANDARD OFFSET 12/14 TAPER SIZE
• 03596010000484: CPCS DISTAL CENTRALIZER SIZE 0MM