Spark

GUDID 00082161404200

Spark Kinetic Calf

BROWNMED, INC.

Hip/knee orthosis

• Primary Device ID: 00082161404200
• NIH Device Record Key: 82aa8bca-61f7-4b0b-91bb-afdb16ab4721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spark
• Version Model Number: 40420
• Company DUNS: 091999771
• Company Name: BROWNMED, 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00082161404200 [Primary]

FDA Product Code

• ISY: Joint, Knee, External Limb Component

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-27
• Device Publish Date: 2020-08-19

On-Brand Devices [Spark]

• 00082161404286: Spark Kinetic Ankle
• 00082161404279: Spark Kinetic Ankle
• 00082161404262: Spark Kinetic Ankle
• 00082161404187: Spark Kinetic Elbow
• 00082161404170: Spark Kinetic Elbow
• 00082161404163: Spark Kinetic Elbow
• 00082161404125: Spark Kinetic Knee
• 00082161404118: Spark Kinetic Knee
• 00082161404101: Spark Kinetic Knee
• 00082161404224: Spark Kinetic Calf
• 00082161404217: Spark Kinetic Calf
• 00082161404200: Spark Kinetic Calf