Silicone PIP TRL-520-3

GUDID 00885556858677

SILICONE PIP SIZING TRIAL SZ. 3

Smith & Nephew, Inc.

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