PlayMakar PRO-1004

GUDID 00856675008236

PLAYMAKAR PRO SELF ADHESIVE ELECTRODES

PLAYMAKAR INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00856675008236
• NIH Device Record Key: 93b081af-eb03-45d5-8cc1-e31f4ff25ddd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlayMakar
• Version Model Number: PRO-1004
• Catalog Number: PRO-1004
• 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856675008106 [Primary]
GS1	00856675008229 [Package]; Contains: 00856675008106; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	00856675008236 [Package]; Contains: 00856675008229; Package: Master Carton [4 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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• 10856675008257: PLAYMAKAR SPORT SNAP ELECTRODES, 2" x 2", 4/Pack
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• 20856675008056: PLAYMAKAR PRO EXPANDABLE WIRELESS PODS
• 00856675008168: PLAYMAKAR SPORT MUSCLE STIMULATOR
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• 00856675008205: PLAYMAKAR PRO SELF ADHESIVE ELECTRODES, 2.75" X 2.75", 4/PACK
• 10856675008011: PLAYMAKAR MINI WIRELESS TENS UNIT
• 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)