Silicone PIP TRL-520-3

GUDID 00885556858677

SILICONE PIP SIZING TRIAL SZ. 3

Smith & Nephew, Inc.

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: 00885556858677
• NIH Device Record Key: 55360492-fdf8-4765-95e4-d7475546e036
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone PIP
• Version Model Number: TRL-520-3
• Catalog Number: TRL-520-3
• 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	00885556858677 [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

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

Moist Heat or Steam Sterilization

[00885556858677]

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 [Silicone PIP]

• 00885556858271: SPIP TRIAL CADDY (CASE)
• 00885556858264: SPIP TRIAL CADDY LID
• 00885556858257: SPIP BASE
• 00885556858226: SILICONE PIP PROXIMAL BROACH SZ. 5
• 00885556858219: SILICONE PIP DISTAL BROACH SZ. 5
• 00885556858202: SILICONE PIP PROXIMAL BROACH SZ. 4
• 00885556858196: SILICONE PIP DISTAL BROACH SZ. 4
• 00885556858189: SILICONE PIP PROXIMAL BROACH SZ. 3
• 00885556858172: SILICONE PIP DISTAL BROACH SZ. 3
• 00885556858165: SILICONE PIP PROXIMAL BROACH SZ. 2
• 00885556858158: SILICONE PIP DISTAL BROACH SZ. 2
• 00885556858141: SILICONE PIP PROXIMAL BROACH SZ. 1
• 00885556858134: SILICONE PIP DISTAL BROACH SZ. 1
• 00885556858127: SILICONE PIP PROXIMAL BROACH SZ. 0
• 00885556858110: SILICONE PIP DISTAL BROACH SZ. 0
• 00885556858028: STARTER AWL ASSEMBLY
• 00885556858691: SILICONE PIP SIZING TRIAL SZ. 5
• 00885556858684: SILICONE PIP SIZING TRIAL SZ. 4
• 00885556858677: SILICONE PIP SIZING TRIAL SZ. 3
• 00885556858660: SILICONE PIP SIZING TRIAL SZ. 2
• 00885556858653: SILICONE PIP SIZING TRIAL SZ. 1
• 00885556858646: SILICONE PIP SIZING TRIAL SZ. 0
• 00885556858547: SILICONE PIP SZ. 5
• 00885556858530: SILICONE PIP SZ. 4
• 00885556858523: SILICONE PIP SZ. 3
• 00885556858516: SILICONE PIP SZ. 2
• 00885556858509: SILICONE PIP SZ. 1
• 00885556858493: SILICONE PIP SZ. 0