PyroCarbon PIP Total Joint System TRL-202-40D

GUDID 00885556858622

PIP DISTAL TI TRIAL SZ. 40

Smith & Nephew, Inc.

Surgical implant template, reusable

• Primary Device ID: 00885556858622
• NIH Device Record Key: 22e04760-5d59-48c3-9e3c-4f93d9df600d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PyroCarbon PIP Total Joint System
• Version Model Number: TRL-202-40D
• Catalog Number: TRL-202-40D
• 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	00885556858622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082231

FDA Product Code

• KYJ: Prosthesis, finger, constrained, polymer

Sterilization

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

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

Moist Heat or Steam Sterilization

[00885556858622]

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 [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