EMA

GUDID 00842326100589

EMA first step kit with 120mm disc

The Myerson Company Limited

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00842326100589
• NIH Device Record Key: 975bf9fb-9231-48bc-abac-8d96a4a4a8c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMA
• Version Model Number: EMAFSK120
• Company DUNS: 857278431
• Company Name: The Myerson Company Limited
• 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: true
• 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

Customer Support Contacts

• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com
• Phone: 18004232683
• Email: orders@myersontooth.com

Device Dimensions

• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter
• Outer Diameter: 120 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842326100589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971794

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-09
• Device Publish Date: 2016-09-24

On-Brand Devices [EMA]

• 00842326100589: EMA first step kit with 120mm disc
• 00842326100572: EMA first step kit with 125mm disc
• 00842326100565: EMA first step kit with 5x5 square sheets
• 00842326100558: EMA Repair Kit
• 00842326100541: EMA Kit4 with 120mmx2.5mm disc
• 00842326100534: EMA Kit3 with 120mmx2.0mm disc
• 00842326100527: EMA Kit2 with 125mmx2.5mm disc
• 00842326100510: EMA Kit1 with 125mmx2.0mm disc
• 00842326100503: Elastic Strap Assortment
• 00842326100497: 125mmx0.035mm vacuum sheet-round
• 00842326100480: 120mmx0.035mm vacuum sheet-round
• 00842326100473: 5x5 EMA first step vacuum forming sheets
• 00842326100466: EMA Thermoforming Disc, 125mmx2.5mm thick
• 00842326100459: EMA Thermoforming Disc, 120mmx2.5mm thick
• 00842326100442: EMA Thermoforming Disc, 125mmx2.0mm thick
• 00842326100435: EMA Thermoforming Disc, 120mmx2.0mm thick
• 00842326100428: EMA first step maxillary buttons (2 pieces) & EMA first step maxillary buttons with bite pads at
• 00842326100411: EMA Buttons (4 pieces)
• 00842326100404: EMA Bite Pads (2 pieces)
• 00842326100381: EMA Strap 21mm White/Soft (25 pieces)
• 00842326100374: EMA Strap 20mm White/Soft (25 pieces)
• 00842326100367: EMA Strap 19mm White/Soft (25 pieces)
• 00842326100350: EMA Strap 18mm White/Soft (25 pieces)
• 00842326100343: EMA Strap 17mm White/Soft (25 pieces)
• 00842326100336: EMA Strap 16mm White/Soft (25 pieces)
• 00842326100329: EMA Strap 15mm White/Soft (25 pieces)
• 00842326100312: EMA Strap 14mm White/Soft (25 pieces)
• 00842326100305: EMA Strap 13mm White/Soft (25 pieces)
• 00842326100282: EMA Strap 21mm Yellow/Medium (25 pieces)
• 00842326100275: EMA Strap 20mm Yellow/Medium (25 pieces)
• 00842326100268: EMA Strap 19mm Yellow/Medium (25 pieces)
• 00842326100251: EMA Strap 18mm Yellow/Medium (25 pieces)
• 00842326100244: EMA Strap 17mm Yellow/Medium (25 pieces)
• 00842326100237: EMA Strap 16mm Yellow/Medium (25 pieces)
• 00842326100220: EMA Strap 15mm Yellow/Medium (25 pieces)
• 00842326100213: EMA Strap 14mm Yellow/Medium (25 pieces)
• 00842326100206: EMA Strap 13mm Yellow/Medium (25 pieces)
• 00842326100183: EMA Strap 21mm Blue/Firm (25 pieces)
• 00842326100176: EMA Strap 20mm Blue/Firm (25 pieces)
• 00842326100169: EMA Strap 19mm Blue/Firm (25 pieces)
• 00842326100152: EMA Strap 18mm Blue/Firm (25 pieces)
• 00842326100145: EMA Strap 17mm Blue/Firm (25 pieces)
• 00842326100138: EMA Strap 16mm Blue/Firm (25 pieces)
• 00842326100121: EMA Strap 15mm Blue/Firm (25 pieces)
• 00842326100114: EMA Strap 14mm Blue/Firm (25 pieces)
• 00842326100107: EMA Strap 13mm Blue/Firm (25 pieces)
• 00842326100084: EMA Strap 21mm Clear/Extra Firm (25 pieces)
• 00842326100077: EMA Strap 20mm Clear/Extra Firm (25 pieces)
• 00842326100060: EMA Strap 19mm Clear/Extra Firm (25 pieces)
• 00842326100053: EMA Strap 18mm Clear/Extra Firm (25 pieces)