IMAGE MH L.C REFILL SYRINGE C2

GUDID 00303620000925

SEPTODONT, INC

Dental composite resin

• Primary Device ID: 00303620000925
• NIH Device Record Key: b2ad0bfc-73a6-481c-82e9-288efa574a11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAGE MH L.C REFILL SYRINGE C2
• Version Model Number: 01C2091
• Company DUNS: 012925513
• Company Name: SEPTODONT, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com

Device Dimensions

• Weight: 4.5 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303620000925 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2016-09-12

Devices Manufactured by SEPTODONT, INC

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• 13760140703622 - R.T.R Membrane: 2021-02-08 Absorbable Collagen Membrane (30X40MM) for dental surgery.
• 00303620000291 - EARLOOP FACE MASK BLUE 3 PLY (2115): 2020-05-06 FACEMASK BLUE E/L
• 00303620000307 - EARLOOP FACE MASK PINK 3 PLY (2116): 2020-05-06 FACEMASK PINK E/L
• 00303620000314 - EARLOOP FACE MASK WHITE 3 PLY (2130): 2020-05-06 MASK E/L WH L1
• 00303620000109 - 2 INCH CLEAR CONT NYL FILM (0002): 2019-11-08 2 INCH CLEAR CONT NYL FILM (0002)
• 00303620000116 - 3 INCH CLEAR CONT NYLON FILM (0003): 2019-11-08 3 INCH CLEAR CONT NYLON FILM (0003)