Ensemble CMC 103-RSP-003

GUDID 00810063560201

Ensemble Orthopedics, Inc.

Metacarpal prosthesis

• Primary Device ID: 00810063560201
• NIH Device Record Key: 7e5ed943-8106-462e-94b9-9e54f7b3c326
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ensemble CMC
• Version Model Number: Ensemble CMC Bump Rasp
• Catalog Number: 103-RSP-003
• Company DUNS: 004115364
• Company Name: Ensemble Orthopedics, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810063560201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201072

FDA Product Code

• KYI: Prosthesis, Wrist, Carpal Trapezium

Sterilization

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

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

[00810063560201]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-09
• Device Publish Date: 2023-08-01

On-Brand Devices [Ensemble CMC]

• 00810063560096: Ensemble Instrument Tray
• 00810063560072: Ensemble CMC Trial, Size 161
• 00810063560065: Ensemble CMC Trial, Size 151
• 00810063560058: Ensemble CMC Trial, Size 141
• 00810063560041: Ensemble CMC Saddle Rasp
• 00810063560034: Ensemble CMC Peripheral Rasp
• 00810063560027: Ensemble CMC Implant, Size 161
• 00810063560010: Ensemble CMC Implant, Size 151
• 00810063560003: Ensemble CMC Implant, Size 141
• 00810063560089: Ensemble CMC Implant Holder
• 00810063560201: Ensemble CMC Bump Rasp