BIOCRYL ICE 5# POLYMER

GUDID D7750470050

GREAT LAKES ORTHODONTICS, LTD.

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• Primary Device ID: D7750470050
• NIH Device Record Key: 2657d643-5719-40a8-8d2c-d7a97dbd7520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOCRYL ICE 5# POLYMER
• Version Model Number: 047-005
• Company DUNS: 041854332
• Company Name: GREAT LAKES ORTHODONTICS, LTD.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7750470050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112397

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2018-07-06
• Device Publish Date: 2016-08-11

Devices Manufactured by GREAT LAKES ORTHODONTICS, LTD.

• D7753004000 - SM DRYFIELD KIT RED *I: 2018-10-05 SM DRYFIELD KIT RED *I
• D7753004010 - LG DRYFIELD KIT WHITE *I: 2018-10-05 LG DRYFIELD KIT WHITE *I
• D7753004060 - RETRACTOR - LARGE WHITE *I: 2018-10-05 RETRACTOR - LARGE WHITE *I
• D7753004140 - RETRACTOR - SMALL RED *I: 2018-10-05 RETRACTOR - SMALL RED *I
• D7753006120 - LARGE LIP RETRACTOR *O: 2018-10-05 LARGE LIP RETRACTOR *O
• D7753006140 - SMALL LIP RETRACTOR *O: 2018-10-05 SMALL LIP RETRACTOR *O
• D7753006260 - GL INTRAORAL MOUTH PROPS: 2018-10-05 GL INTRAORAL MOUTH PROPS
• D7753006270 - GL INTRAORAL MOUTH PROPS: 2018-10-05 GL INTRAORAL MOUTH PROPS