PlayMakar PRO-275

GUDID 00856675008205

PLAYMAKAR PRO SELF ADHESIVE ELECTRODES, 2.75" X 2.75", 4/PACK

PLAYMAKAR INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00856675008205
• NIH Device Record Key: e1d92fce-b2ae-4c34-8a65-3180bf09229c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlayMakar
• Version Model Number: PRO-275
• Catalog Number: PRO-275
• Company DUNS: 081212270
• Company Name: PLAYMAKAR 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com
• Phone: 8337529625
• Email: IAM@PlayMakar.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856675008021 [Primary]
GS1	00856675008205 [Package]; Contains: 00856675008021; Package: Master Carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082065

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2019-03-11
• Device Publish Date: 2019-02-22

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• 00856675008007: PLAYMAKAR PRO STRENGTH AND RECOVERY SYSTEM
• 00856675008755: PLAYMAKAR PRO STRENGTH AND RECOVERY SYSTEM (4 Pods)
• 00856675008724: PLAYMAKAR PRO STRENGTH AND RECOVERY SYSTEM (2 Pods)