PyroCarbon Lunate LUN-710-05-WW

GUDID 00885556858769

LUNATE SZ. 05

Smith & Nephew, Inc.

Carpal lunate prosthesis

• Primary Device ID: 00885556858769
• NIH Device Record Key: bd8a3eaa-f769-40c7-be92-6f4e8a9f7d70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PyroCarbon Lunate
• Version Model Number: LUN-710-05-WW
• Catalog Number: LUN-710-05-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	00885556858769 [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