Comfortox

GUDID 00817169021940

.3 CC 31 Gauge X 8 MM 100

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Insulin syringe/needle, basic

• Primary Device ID: 00817169021940
• NIH Device Record Key: 2e7b5f63-702a-479f-ae01-8cddd190235a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfortox
• Version Model Number: .3 CC 31 Gauge X 8 MM 100
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Suggested storage condition:25℃, and the RH shouldn't exceed 60%. Avoid the direct sunlight, no corrosive gas.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817169021940 [Primary]
GS1	10817169021947 [Package]; Package: [36 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: 2018-05-14
• Device Publish Date: 2018-04-12

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