First Choice Modular Ulnar Head Implant TRL-600-H160

GUDID 00885556826584

MUH HEAD TRIAL SZ. 16

Smith & Nephew, Inc.

Surgical implant template, reusable

• Primary Device ID: 00885556826584
• NIH Device Record Key: 29a3745a-d5de-4c9f-b64e-b5b797b4701d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First Choice Modular Ulnar Head Implant
• Version Model Number: TRL-600-H160
• Catalog Number: TRL-600-H160
• 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	00885556826584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112481

FDA Product Code

• KXE: Prosthesis, wrist, hemi-, ulnar

Sterilization

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

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

Moist Heat or Steam Sterilization

[00885556826584]

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: 2022-12-21

On-Brand Devices [First Choice Modular Ulnar Head Implant]

• 00885556826324: MUH OSTEOTOMY GUIDE
• 00885556826317: MUH RESECTION GUIDE
• 00885556826171: MUH STEM IMPACTOR
• 00885556826089: MUH REAMER SZ. 6.5
• 00885556826072: MUH REAMER SZ. 5.5
• 00885556826065: MUH REAMER SZ. 4.5
• 00885556826058: MUH REAMER SZ. 3.5
• 00885556826300: MUH STEM SZ. 6.5 S
• 00885556826294: MUH STEM SZ. 6.5 M
• 00885556826287: MUH STEM SZ. 6.5 L
• 00885556826270: MUH STEM SZ. 5.5 S
• 00885556826263: MUH STEM SZ. 5.5 M
• 00885556826256: MUH STEM SZ. 5.5 L
• 00885556826249: MUH STEM SZ. 4.5 S
• 00885556826232: MUH STEM SZ. 4.5 M
• 00885556826225: MUH STEM SZ. 4.5 L
• 00885556826218: MUH HEAD SZ. 19.0
• 00885556826201: MUH HEAD SZ. 17.5
• 00885556826195: MUH HEAD SZ. 16.0
• 00885556826652: MUH STEM TRIAL SZ. 6.5
• 00885556826645: MUH STEM TRIAL SZ. 5.5
• 00885556826638: MUH STEM TRIAL SZ. 4.5
• 00885556826614: MUH TRIAL COLLAR LONG
• 00885556826607: MUH HEAD TRIAL SZ. 19
• 00885556826591: MUH HEAD TRIAL SZ. 17.5
• 00885556826584: MUH HEAD TRIAL SZ. 16
• 00885556826188: MUH BACK TABLE ASSY PAD
• 00885556826096: MUH INSTRUMENT CASE BASE