PyroSphere CMC TRL-435-20

GUDID 00885556830857

PYROSPHERE TRIAL SZ. 20

Smith & Nephew, Inc.

Carpometacarpal interpositional spacer prosthesis trial

• Primary Device ID: 00885556830857
• NIH Device Record Key: 05c30666-7ed9-417e-934f-9e4efac035fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PyroSphere CMC
• Version Model Number: TRL-435-20
• Catalog Number: TRL-435-20
• Company DUNS: 045483575
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556830857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042690

FDA Product Code

• KYI: Prosthesis, wrist, carpal trapezium

Sterilization

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

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

[00885556830857]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-07
• 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