Original D Capsules 3 Spill Regular Set 50 count

GUDID 00853383006332

Wykle Research, Inc

Dental amalgam

• Primary Device ID: 00853383006332
• NIH Device Record Key: d029ef03-2b23-4eec-8626-64876e5b67d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Original D Capsules 3 Spill Regular Set 50 count
• Version Model Number: 61353-03
• 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	00853383006332 [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

Devices Manufactured by Wykle Research, Inc

• 00853383006011 - Original D Capsules 1 Spill Fast Set 50 count: 2018-07-12
• 00853383006158 - Original D Tablets Fast Set 10 oz: 2018-07-12
• 00853383006202 - Original D Capsules 2 Spill Fast Set 100 count: 2018-07-12
• 00853383006035 - Wykalloy Capsules 1 Spill 50 count: 2018-07-06
• 00853383006042 - Wykalloy Capsules 2 Spill 50 count: 2018-07-06
• 00853383006059 - Wykalloy Capsules 3 Spill 50 count: 2018-07-06
• 00853383006066 - Wykalloy Capsules 1 Spill 500 count: 2018-07-06
• 00853383006073 - Wykalloy Capsules 2 Spill 500 count: 2018-07-06