BioMotion Cannulated 1st MPJ Hemi System HM2100

GUDID 00885556821718

CANNULATED HEMI IMPLANT LARGE (21MM)

Smith & Nephew, Inc.

Wrist ulna-head prosthesis

• Primary Device ID: 00885556821718
• NIH Device Record Key: cca2b5bc-423f-45f5-afb8-93fcf373b298
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioMotion Cannulated 1st MPJ Hemi System
• Version Model Number: HM2100
• Catalog Number: HM2100
• 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: true
• 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	00885556821718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083469

FDA Product Code

• KWD: PROSTHESIS, TOE, HEMI-, PHALANGEAL

Sterilization

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

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

Moist Heat or Steam Sterilization

[00885556821718]

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 [BioMotion Cannulated 1st MPJ Hemi System]

• 00885556821831: HEMI GUIDE WIRE SMOOTH .062IN X 4IN
• 00885556821824: HEMI STERILIZATION TRAY LID ONLY
• 00885556821817: HEMI STERILIZATION TRAY
• 00885556821800: BIOMOTION HEMI RASP
• 00885556821794: CANNULATED HEMI SIZER XLARGE (23MM)
• 00885556821787: CANNULATED HEMI SIZER LARGE (21MM)
• 00885556821770: CANNULATED HEMI SIZER MEDIUM (19MM)
• 00885556821763: CANNULATED HEMI SIZER SMALL (17MM)
• 00885556821756: CANNULATED HEMI SIZER XSMALL (15MM)
• 00885556821749: BIOMOTION SLIDE HAMMER
• 00885556821732: BIOMOTION SLIDE BROACH
• 00885556821725: CANNULATED HEMI IMPLANT XLARGE (23MM)
• 00885556821718: CANNULATED HEMI IMPLANT LARGE (21MM)
• 00885556821701: CANNULATED HEMI IMPLANT MEDIUM (19MM)
• 00885556821695: CANNULATED HEMI IMPLANT SMALL (17MM)
• 00885556821688: CANNULATED HEMI IMPLANT XSMALL (15MM)