Surgical Guide

GUDID 00860002099309

Surgical Guide Resin

FORMLABS OHIO INC.

Dental appliance fabrication material, cured

• Primary Device ID: 00860002099309
• NIH Device Record Key: 2a481aa0-7cc4-4dd6-ba1b-79952cd90605
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Guide
• Version Model Number: FLSGAM01
• Company DUNS: 106744280
• Company Name: FORMLABS OHIO 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002099309 [Primary]
GS1	00860002099316 [Package]; Package: Case [8 Units]; In Commercial Distribution

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

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: 2019-12-05
• Device Publish Date: 2019-11-27

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