COLD AS ICE

GUDID 00852509006027

Endo Freeze Spray

ECOTEC MANUFACTURING, INC.

Cryogenic spray, dental

• Primary Device ID: 00852509006027
• NIH Device Record Key: 90b8a138-bb4b-47af-86b0-a52b9ad08847
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COLD AS ICE
• Version Model Number: 250
• Company DUNS: 121411859
• Company Name: ECOTEC MANUFACTURING, 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2547724661
• Email: savetime@wonderfill.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852509006027 [Primary]
GS1	00852509006058 [Package]; Package: BOX [12 Units]; In Commercial Distribution

FDA Product Code

• IFI: Sprays, Synthetic, Smear

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-21

Devices Manufactured by ECOTEC MANUFACTURING, INC.

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• 00860177000636 - Max Pro Medical Freeze Spray: 2018-09-17 Medical Freeze Spray
• 00860177000629 - ENDODONTIC SPRAY: 2018-04-02 ENDODONTIC SPRAY PULP VITALITY REFRIGERANT
• 00852509006027 - COLD AS ICE: 2018-03-29Endo Freeze Spray
• 00852509006027 - COLD AS ICE: 2018-03-29 Endo Freeze Spray