KARMA MIS

GUDID 00840606169974

Awl Stylet

SPINAL ELEMENTS, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00840606169974
• NIH Device Record Key: 5ac66732-9114-4c5c-8558-9773c79af5a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KARMA MIS
• Version Model Number: 75621-000
• Company DUNS: 610712213
• Company Name: SPINAL ELEMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	00840606169974 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

[00840606169974]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-14
• Device Publish Date: 2022-02-04

On-Brand Devices [KARMA MIS]

• 00840606169974: Awl Stylet
• 00840606169936: Karma® MIS Tray Base
• 00840606169929: Karma® MIS Tray Lower Level Insert
• 00840606169912: Karma® MIS Tray Top Level Insert
• 00840606169905: Karma® MIS Tray Lid
• 00840606169899: Karma® MIS Tray Assembly
• 00840606167956: Karma Tensioner