Modular Radial Head (MRH) System MRH-350-22S-WW

GUDID 00885556857427

MODULAR RADIAL HEAD SZ. 22S WW

Smith & Nephew, Inc.

Elbow radius prosthesis

• Primary Device ID: 00885556857427
• NIH Device Record Key: a6b463fa-b4d0-4441-a602-9fc2f6c1c1d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modular Radial Head (MRH) System
• Version Model Number: MRH-350-22S-WW
• Catalog Number: MRH-350-22S-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
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556857427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032686

FDA Product Code

• KWI: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

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: 2023-07-12
• Device Publish Date: 2022-12-22

On-Brand Devices [Modular Radial Head (MRH) System]

• 00885556866054: MRH PLANAR
• 00885556857489: OSTEOTOMY CUT GUIDE. MRH
• 00885556857472: MRH REAMER SZ. 03
• 00885556857465: MRH REAMER SZ. 02
• 00885556857458: MRH REAMER SZ. 01
• 00885556857335: IMPACTOR. STEM. MRH
• 00885556857441: MODULAR RADIAL HEAD SZ. 24S WW
• 00885556857434: MODULAR RADIAL HEAD SZ. 24L WW
• 00885556857427: MODULAR RADIAL HEAD SZ. 22S WW
• 00885556857410: MODULAR RADIAL HEAD SZ. 22L WW
• 00885556857403: MODULAR RADIAL HEAD SZ. 20S WW
• 00885556857397: MODULAR RADIAL HEAD SZ. 20L WW
• 00885556857380: MODULAR RADIAL HEAD STEM SZ. 04 WW
• 00885556857373: MODULAR RADIAL HEAD STEM SZ. 03 WW
• 00885556857366: MODULAR RADIAL HEAD STEM SZ. 02 WW
• 00885556857359: MODULAR RADIAL HEAD STEM SZ. 01 WW
• 00885556857601: MRH HEAD TRIAL SZ. 24S
• 00885556857595: MRH HEAD TRIAL SZ. 24L
• 00885556857588: MRH HEAD TRIAL SZ. 22S
• 00885556857571: MRH HEAD TRIAL SZ. 22L
• 00885556857564: MRH HEAD TRIAL SZ. 20S
• 00885556857557: MRH HEAD TRIAL SZ. 20L
• 00885556857540: MRH TRIAL. TI. SZ. 24S
• 00885556857533: MRH TRIAL. TI. SZ. 24L
• 00885556857526: MRH TRIAL. TI. SZ. 22S
• 00885556857519: MRH TRIAL. TI. SZ. 22L
• 00885556857502: MRH TRIAL. TI. SZ. 20S
• 00885556857496: MRH TRIAL. TI. SZ. 20L
• 00885556857342: BACK TABLE ASSEMBLY PAD. MRH
• 00885556857311: STEM HOLDER. MRH
• 00885556857304: GENERIC METAL INSTRMT CASE BASE #85-0702
• 00885556857298: GENERIC METAL INSTRMNT CASE LID #85-0701
• 00885556857281: INSTRUMENT CASE. BASE. MRH. #05-3572
• 00885556857267: BROACH. MRH. SZ. 04
• 00885556857250: RADIAL HEAD BROACH SIZE 24
• 00885556857243: RADIAL HEAD BROACH SIZE 22
• 00885556857236: RADIAL HEAD BROACH SIZE 20