PyroCarbon Lunate LUN-710-01-WW

GUDID 00885556858721

LUNATE SZ. 01

Smith & Nephew, Inc.

Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis Carpal lunate prosthesis

• Primary Device ID: 00885556858721
• NIH Device Record Key: 93dd5ce7-138b-48f9-82d2-3031422954a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PyroCarbon Lunate
• Version Model Number: LUN-710-01-WW
• Catalog Number: LUN-710-01-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556858721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080997

FDA Product Code

• KWN: Prosthesis, wrist, carpal lunate

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-20
• Device Publish Date: 2023-02-10

On-Brand Devices [PyroCarbon Lunate]

• 00885556858813: LUNATE SIZING TEMPLATE SZ. 05
• 00885556858806: LUNATE SIZING TEMPLATE SZ. 04
• 00885556858790: LUNATE SIZING TEMPLATE SZ. 03
• 00885556858783: LUNATE SIZING TEMPLATE SZ. 02
• 00885556858776: LUNATE SIZING TEMPLATE SZ. 01
• 00885556858868: LUNATE TRIAL SZ. 05
• 00885556858851: LUNATE TRIAL SZ. 04
• 00885556858844: LUNATE TRIAL SZ. 03
• 00885556858837: LUNATE TRIAL SZ. 02
• 00885556858820: LUNATE TRIAL SZ. 01
• 00885556858769: LUNATE SZ. 05
• 00885556858752: LUNATE SZ. 04
• 00885556858745: LUNATE SZ. 03
• 00885556858738: LUNATE SZ. 02
• 00885556858721: LUNATE SZ. 01
• 00885556858714: LUNATE CASE
• 00885556858707: LUNATE LID