PyroSphere CMC PCS-430-20-WW

GUDID 00885556830758

PCS SZ. 20 PYROSPHERE

Smith & Nephew, Inc.

Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis Metacarpal prosthesis

• Primary Device ID: 00885556830758
• NIH Device Record Key: c60a2ef4-14ce-46d9-9eba-dc71342041b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PyroSphere CMC
• Version Model Number: PCS-430-20-WW
• Catalog Number: PCS-430-20-WW
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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	00885556830758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042690

FDA Product Code

• KWD: PROSTHESIS, TOE, HEMI-, PHALANGEAL
• KYI: Prosthesis, wrist, carpal trapezium

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-06
• Device Publish Date: 2022-12-22

On-Brand Devices [PyroSphere CMC]

• 00885556830734: PCS IMPLANT EXTRACTOR
• 00885556830680: SPHERICAL BURR SZ. 50
• 00885556830673: SPHERICAL BURR SZ. 40
• 00885556830666: SPHERICAL BURR SZ. 30
• 00885556830659: SPHERICAL BURR SZ. 20
• 00885556830642: SPHERICAL BURR SZ. 10
• 00885556830741: PCS SZ. 10 PYROSPHERE
• 00885556830758: PCS SZ. 20 PYROSPHERE
• 00885556830772: PCS SZ. 40 PYROSPHERE
• 00885556830765: PCS SZ. 30 PYROSPHERE
• 00885556830888: PYROSPHERE TRIAL SZ. 50
• 00885556830871: PYROSPHERE TRIAL SZ. 40
• 00885556830864: PYROSPHERE TRIAL SZ. 30
• 00885556830857: PYROSPHERE TRIAL SZ. 20
• 00885556830840: PYROSPHERE TRIAL SZ. 10
• 00885556830789: PCS SZ. 50 PYROSPHERE
• 00885556830727: PHS CASE LID
• 00885556830710: PHS CASE
• 00885556830703: PCS INSTRUMENT CASE BASE
• 00885556830697: PCS INSTRUMENT CASE LID