PyroCarbon PIP Total Joint System PIP-200-40D-WW

GUDID 00885556858455

PIP SZ. 40 DISTAL

Smith & Nephew, Inc.

Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular Proximal interphalangeal joint prosthesis, modular

• Primary Device ID: 00885556858455
• NIH Device Record Key: e56c3b33-59fc-43b7-8fd8-45e87509eda6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PyroCarbon PIP Total Joint System
• Version Model Number: PIP-200-40D-WW
• Catalog Number: PIP-200-40D-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	00885556858455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H010005

FDA Product Code

• OMX: High demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis

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 PIP Total Joint System]

• 00885556858295: PIP. IMPACTOR. PROXIMAL
• 00885556858288: PIP. IMPACTOR. DISTAL
• 00885556858103: PIP. BROACH. PROXIMAL. SZ. 40
• 00885556858097: PIP. BROACH. DISTAL. SZ. 40
• 00885556858080: PIP. BROACH. PROXIMAL. SZ. 30
• 00885556858073: PIP. BROACH. DISTAL. SZ. 30
• 00885556858066: PIP. BROACH. PROXIMAL. SZ. 20
• 00885556858059: PIP. BROACH. DISTAL. SZ. 20
• 00885556858042: PIP. BROACH. PROXIMAL. SZ. 10
• 00885556858035: PIP. BROACH. DISTAL. SZ. 10
• 00885556858462: PIP SZ. 40 PROXIMAL
• 00885556858455: PIP SZ. 40 DISTAL
• 00885556858448: PIP SZ. 30 PROXIMAL
• 00885556858431: PIP SZ. 30 DISTAL
• 00885556858424: PIP SZ. 20 PROXIMAL
• 00885556858417: PIP SZ. 20 DISTAL
• 00885556858400: PIP SZ. 10 PROXIMAL
• 00885556858394: PIP SZ. 10 DISTAL
• 00885556858486: PIP DISPOSABLE PACK FOR STRYKER
• 00885556858479: PIP DISPOSABLE PACK FOR LINVATEC/HALL
• 00885556858639: PIP PROXIMAL TI TRIAL SZ. 40
• 00885556858622: PIP DISTAL TI TRIAL SZ. 40
• 00885556858615: PIP PROXIMAL TI TRIAL SZ. 30
• 00885556858608: PIP DISTAL TI TRIAL SZ. 30
• 00885556858592: PIP PROXIMAL TI TRIAL SZ. 20
• 00885556858585: PIP DISTAL TI TRIAL SZ. 20
• 00885556858578: PIP PROXIMAL TI TRIAL SZ. 10
• 00885556858561: PIP DISTAL TI TRIAL SZ. 10
• 00885556858554: PIP DISTAL TEMPLATE
• 00885556858387: PIP PROX CUT GUIDE. VOLAR APPR. SZ 40
• 00885556858370: PIP. PROXIMAL CUT GUIDE. SZ. 40
• 00885556858363: PIP PROX CUT GUIDE. VOLAR APPR. SZ 30
• 00885556858356: PIP. PROXIMAL CUT GUIDE. SZ. 30
• 00885556858349: PIP PROX CUT GUIDE. VOLAR APPR. SZ 20
• 00885556858332: PIP. PROXIMAL CUT GUIDE. SZ. 20
• 00885556858325: PIP PROX CUT GUIDE. VOLAR APPR. SZ 10
• 00885556858318: PIP. PROXIMAL CUT GUIDE. SZ. 10
• 00885556858301: PIP VERTICAL CUT GUIDE
• 00885556858240: PIP INSTRUMENT CASE INSERT
• 00885556858233: PIP INSTRUMENT CASE BASE