Comfortox

GUDID 10817169023521

Comfortox Sterile syringes /with needle 3ml/cc 22gx1"

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Insulin syringe/needle, basic

• Primary Device ID: 10817169023521
• NIH Device Record Key: 0087a7ed-d0c1-4fa3-bd6e-546a1c6b6b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfortox
• Version Model Number: 3ml/cc 22gx1"
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817169023524 [Primary]
GS1	10817169023521 [Package]; Contains: 00817169023524; Package: Pack [100 Units]; In Commercial Distribution

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-18

On-Brand Devices [Comfortox]

• 00817169021957: .5 CC 31 Gauge X 8 MM 100
• 00817169021940: .3 CC 31 Gauge X 8 MM 100
• 10817169023521: Comfortox Sterile syringes /with needle 3ml/cc 22gx1"
• 00810126506764: Comfortox Sterile syringes /with needle 0.5cc 29g x 8mm Box/100
• 00810126506757: Comfortox Sterile syringes /with needle 0.5cc 30g x 13mm Box/100