Original D Capsules 2 Spill Extra Fast Set 500 count

GUDID 00853383006196

Wykle Research, Inc

Dental amalgam

• Primary Device ID: 00853383006196
• NIH Device Record Key: 8abc7388-929b-4e7b-8f3c-98d505a5ac1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Original D Capsules 2 Spill Extra Fast Set 500 count
• Version Model Number: 61242-03
• Company DUNS: 614557155
• Company Name: Wykle Research, 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853383006196 [Primary]

FDA Product Code

• OIV: Dental Amalgam

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: 2016-09-23

On-Brand Devices [Original D Capsules 2 Spill Extra Fast Set 500 count]

• 00853383006196: 61242-03
• 00853383006134: 61232-03