First Choice Modular Ulnar Head Implant MUH-600-S45S-WW

GUDID 00885556826249

MUH STEM SZ. 4.5 S

Smith & Nephew, Inc.

Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis Wrist ulna-head prosthesis

• Primary Device ID: 00885556826249
• NIH Device Record Key: 9f927b73-2ae7-4178-a9e8-cdb4eb326b28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First Choice Modular Ulnar Head Implant
• Version Model Number: MUH-600-S45S-WW
• Catalog Number: MUH-600-S45S-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	00885556826249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052137

FDA Product Code

• KXE: Prosthesis, wrist, hemi-, ulnar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-11
• 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